CompletedPhase 3

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

42 participantsStarted 2004-09

Plain-language summary

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.

Who can participate

Age range3 Years – 70 Years

SexALL

See this in plain English?

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

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

What they're measuring

Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

Trial details

NCT IDNCT00168012

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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