ASIS for GAMMAGARD in Primary Immunodeficiency

NCT ID: NCT02123615

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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ASIS Corporation (ASIS) has developed the only automatic injection system for delivery of injectable products to it's optimum/right spot, just outside of the fascia, which exists subdermally (between the skin and muscle). Bloodless basically implies longer lasting medicinal effects, and minimal side effects - advantages that reflect the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability. ASIS device is stabilized on the surface of the skin with negative pressure and emits an electrical current to create a bloodless cavity subdermally. ASIS device correctly, automatically, and consistently delivers therapeutic agents, yet requiring little skill of a practitioner - providing the steady and safe infusion into subdermal bloodless space of virtually any injectable product in addition to Botox, including GAMMAGARD LIQUID, Enbrel, Insulin, and Fillers, etc. According to the FDA, "This innovation will have major impact on the healthcare industry."

Detailed Description

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Aim 1 would require 6 months, to demonstrate ASIS device's consistent performance on 60 subjects with Primary Immunodeficiency (PI), and the particular skin affected by this disease.

30 subjects will receive Gadolinium subcutaneously, and 30 subjects will receive Gadolinium subdermally with ASIS device. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g.

GAMMAGARD) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Primary Immunodeficiency (PI), and the particular skin affected by it. Case in point, Primary Immunodeficiency (PI) patients are prone to infection, and tend to have scared skin with less vascularity, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which will be very different from the skin of normal patients, while the Gadolinium subdermally Persistent % may or may not change. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over that of total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Primary Immunodeficiency. However, they are valuable indicators that will help us modify the GAMMAGARD dosage and duration to inject into that "unknown" subdermal space for Aim 2.

Aim 2 would require 12 months, using GAMMAGARD, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over subcutaneously, for the same Primary Immunodeficiency subjects. Of course that Relative Prolongation Ability Score in Aim1 will be valuable, but it isn't absolutely required to start Aim 2, because GAMMAGARD's Pharmacokinetics will be studied anyway, by following Peak and Trough levels of immunoglobulin G.

However, the Pharmacokinetics of subdermally injected GAMMAGARD will be just dependent on GAMMAGARD's diffusion out of that subdermal bloodless space; therefore, if GAMMAGARD getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of GAMMAGARD in the end. The therapeutic advantages of GAMMAGARD with ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of Validated Acute Serious Bacterial Infections, adverse reactions, and injection site pain.

Conditions

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Primary Immunodeficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gadolinium For abdomen

Gadolinium For abdomen Total Persistent % subdermally, For abdomen Total Persistent % subcutaneously, and For abdomen Relative Prolongation Ability Score.

Gadolinium Magnevist® (gadopentetate dimeglumine)

1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

Group Type EXPERIMENTAL

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .

Gadolinium For lower back

1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg), subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

Gadolinium For lower back Total Persistent % subdermally, For lower back Total Persistent % subcutaneously, and For lower back Relative Prolongation Ability Score.

Group Type EXPERIMENTAL

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.

Gadolinium For abdomen

Intervention Type DRUG

Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Gadolinium For lower back

Intervention Type DRUG

Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .

subjects (%) of any infections

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Annual rate of any infections

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

subjects (%) with Antibiotic use

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Annual rate with Antibiotic use

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

subjects (%) with Days out of work

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Annual rate with Days out of work

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

(%) with hospitalized infections

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Annual rate hospitalized infections

Annual rate hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12, Efficacy of Gammagard subcutaneously at Week 24, and Efficacy of Gammagard subcutaneously at Week 36, vs. Efficacy of Gammagard subdermally at Week 12, Efficacy of Gammagard subdermally at Week 24, and Efficacy of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subcutaneously at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 24

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Efficacy of Gammagard subdermally at Week 36

Intervention Type DRUG

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Adverse Injection Local Reactions

Adverse Injection Local Reactions as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Headache

Headache as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Fever

Fever as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Nausea

Nausea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Vomiting

Vomiting as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Fatigue

Fatigue as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Diarrhea

Diarrhea as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Asthma

Asthma as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Oropharyngeal

Oropharyngeal as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions Abdominal Pain

Abdominal Pain as Adverse Reactions of Gammagard subcutaneously at Week 12, Adverse Reactions of Gammagard subcutaneously at Week 24, and Adverse Reactions of Gammagard subcutaneously at Week 36, vs. Adverse Reactions of Gammagard subdermally at Week 12, Adverse Reactions of Gammagard subdermally at Week 24, and Adverse Reactions of Gammagard subdermally at Week 36.

Group Type EXPERIMENTAL

Adverse Reactions of Gammagard subcutaneously at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subcutaneously at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 12

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Adverse Reactions of Gammagard subdermally at Week 24

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Adverse Reactions of Gammagard subdermally at Week 36

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gadolinium For abdomen

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type DRUG

Gadolinium For abdomen

Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs.

Intervention Type DRUG

Gadolinium For abdomen

Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Intervention Type DRUG

Gadolinium For lower back

Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subdermally with ASIS Device for 30 patients.

Intervention Type DRUG

Gadolinium For lower back

Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for \<40kg) or 29cc normal saline (for \>40kg) subcutaneously for 30 patients.

Intervention Type DRUG

Gadolinium For lower back

Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 12

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 24

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 36

subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 36

Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 36

subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 36

Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subcutaneously at Week 36

subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 12

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 24

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Efficacy of Gammagard subdermally at Week 36

Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 12

Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 24

Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type DRUG

Adverse Reactions of Gammagard subcutaneously at Week 36

Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 12

Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 24

Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type DRUG

Adverse Reactions of Gammagard subdermally at Week 36

Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.

Intervention Type DRUG

Other Intervention Names

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Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gadolinium Magnevist® (gadopentetate dimeglumine) Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)] Gammagard [Immune Globulin Infusion (Human)]

Eligibility Criteria

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Inclusion Criteria

* Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: Yes
* Must be outpatient, male or female, of any race, between 18 and 65 years of age.
* Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
* Must be in good general health as determined by investigator.
* If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception

* Patients 12 years or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies1,2.

Exclusion Criteria

* Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ASIS Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

Thanh Phung, MD

Role: PRINCIPAL_INVESTIGATOR

AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

Hanh Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

AUTOMATIC SUBDERMAL INJECTOR SYSTEM,INC

Locations

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Automatic Subdermal Injector System, Inc

Westminster, California, United States

Site Status

Countries

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United States

Central Contacts

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Li Nguyen, MD

Role: CONTACT

(714)-453-7857

Thanh Phung, MD

Role: CONTACT

714-893-1915

Facility Contacts

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Li Nguyen, MD

Role: primary

714-453-7857

Thanh Phung, MD

Role: backup

(714)-893-1915

References

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Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.

Reference Type BACKGROUND
PMID: 980495 (View on PubMed)

Magnevist (gadopentetate dimeglumine) Injection Product Information: http://pharma.bayer.com/scripts/pages/en/products/diagnostic_imaging/index.php

Reference Type BACKGROUND

Botox (onabotulinumtoxinA) Product Information: http://www.botoxcosmetic.com/botox_physician_info/Clinical_Information.aspx http://www.clinicaltrials.gov/ct2/show/NCT01313767?term=Botox+pi&rank=1

Reference Type BACKGROUND

GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID): http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5

Reference Type BACKGROUND

Daw Z, Padmore R, Neurath D, Cober N, Tokessy M, Desjardins D, Olberg B, Tinmouth A, Giulivi A. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion. 2008 Aug;48(8):1598-601. doi: 10.1111/j.1537-2995.2008.01721.x. Epub 2008 May 2.

Reference Type BACKGROUND
PMID: 18466176 (View on PubMed)

Mignogna MD, Fortuna G, Ruoppo E, Adamo D, Leuci S, Fedele S. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat? Am J Clin Dermatol. 2007;8(5):291-9. doi: 10.2165/00128071-200708050-00004.

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Related Links

Access external resources that provide additional context or updates about the study.

http://www.asis-inc.com

Click here for more information about this study ASIS for GAMMAGARD in Primary Immunodeficiency

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01EB017805

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCTEB017805

Identifier Type: -

Identifier Source: org_study_id

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