CompletedPhase 3

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

United States55 participantsStarted 2005-11

Plain-language summary

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.

Who can participate

Age range4 Years – 71 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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 Key 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

What they're measuring

The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).

Timeframe: During each infusion, and within 48 or 72 hours after the end of each infusion.

Influence of Infusion Rate on Temporally-Associated AEs

Timeframe: Within 72 hours after each infusion

Rate of AEs by Severity and Relationship

Timeframe: For the duration of the study, up to approximately 29 months

Number of Subjects With Clinically Significant Changes in Vital Signs.

Timeframe: Before, during, and after each infusion.

Trial details

NCT IDNCT00322556

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-04

Results submitted2012-09-27

View on ClinicalTrials.gov More Agammaglobulinemia trials