Status:
TERMINATED
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
Lead Sponsor:
Octapharma
Conditions:
Immunologic Deficiency Syndromes
Eligibility:
All Genders
2-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00811174
Start Date
January 1 2009
End Date
September 1 2010
Last Update
July 14 2017
Active Locations (1)
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1
Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information
Vienna, Austria, 1100