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

CSL Behring42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Interventions

Immunoglobulins Intravenous (Human)DRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Rate of acute serious bacterial infections

Number of days out of work/school due to underlying PID

Number of infections

Rate, severity and relationship of all adverse events

Data from ClinicalTrials.gov

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