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Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

NCT ID: NCT00322556

Last Updated: 2012-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-04-30

Brief Summary

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The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Detailed Description

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Conditions

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Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Keywords

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Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia Common variable immunodeficiency Immunoglobulin G Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IgPro10

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Group Type EXPERIMENTAL

Immunoglobulins Intravenous (Human)

Intervention Type DRUG

Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Interventions

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Immunoglobulins Intravenous (Human)

Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:

Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03\_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

OR

Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04\_009CR) (referred to as 'new' subjects)

Written informed consent

Exclusion Criteria

Diagnosis of epilepsia

Insulin dependent diabetes

Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs

History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Minimum Eligible Age

4 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Program Coordinator

Role: STUDY_DIRECTOR

CSL Behring

Locations

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Los Angeles, California, United States

Site Status

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Centennial, Colorado, United States

Site Status

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North Palm Beach, Florida, United States

Site Status

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St. Petersburg, Florida, United States

Site Status

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Fort Wayne, Indiana, United States

Site Status

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Indianapolis, Indiana, United States

Site Status

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Iowa City, Iowa, United States

Site Status

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Rochester, Minnesota, United States

Site Status

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St Louis, Missouri, United States

Site Status

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Dallas, Texas, United States

Site Status

Countries

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United States

References

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Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10.

Reference Type RESULT
PMID: 20217199 (View on PubMed)

Other Identifiers

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ZLB05_006CR

Identifier Type: -

Identifier Source: org_study_id