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Efficacy and Safety of Intrav...

Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

Last Updated: 2011-02-11

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.

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Detailed Description

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Conditions

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Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Immunoglobulins Intravenous (Human)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with primary immunodeficiency
* Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Exclusion Criteria

* Allergic reactions to immunoglobulins or other blood products
* Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
* History of cardiac insufficiency
* Epilepsia

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers