Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma
• Treatments: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of primary immunodeficiency (acc. WHO)

• Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals

• Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both

Exclusion Criteria:

• Acute infection requiring intravenous antibiotic treatment within two weeks before screening

• Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months

• History of hypersensitivity to blood or plasma derived products

• Requirement of any routine premedication for IGIV treatment

• History of congenital impairment of pulmonary function

• Severe liver function impairment

• Severe renal function impairment or predisposition for acute renal failure

• History of autoimmune haemolytic anaemia

• History of diabetes mellitus

• Congestive heart failure NYHA III or IV

• Non-controlled arterial hypertension

• History of DVT or thrombotic complications with IGIV treatment

• Known infection with HIV, HCV or HBV

• Treatment with steroids, immunosuppressive or immunomodulatory drugs

• Planned vaccination during study period

• Pregnant or nursing woman