Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Immunoglobulins

Criteria

Key Inclusion Criteria:

• Written informed consent, age-adapted

• Male or female aged 1 to 70 years

• Diagnosis of primary humoral immunodeficiency

• No prior immunoglobulin substitution therapy

• IgG level of <5 g/L at screening

• Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening

Key Exclusion Criteria:

• Evidence of serious infection between screening and first treatment

• Bleeding disorders that require medical treatments

• Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity

• Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial