Clinical study to evaluate the efficacy and safety of Octagam 5% in patients with Primary Immunodeficiency diseases (PID)
- Conditions
- Primary Immunodeficiency diseases (PID)Haematological DisordersImmunodeficiency with predominantly antibody defects, unspecified
- Registration Number
- ISRCTN32382999
- Lead Sponsor
- Octapharma (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
1. Age between 18 years and 75 years
2. Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency
3. Previously treated with a commercial IVIG every 21?28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
4. Availability of the IgG trough levels of the 2 previous infusions before enrolment
1. Acute infection
2. Known history of adverse reactions to IgA in other products
3. Exposure to blood or any blood product, other than commercially available IVIG, within the past 3 months prior to enrolment
4. Congestive heart failure NYHA class III or IV
5. Non-controlled arterial hypertension
6. History of deep vein thrombosis
7. Known HIV, HCV, or HBV infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the PK profile of Octagam with respect to total IgG, IgG subclasses
- Secondary Outcome Measures
Name Time Method The following parameters will be used in the safety and tolerability assessment of the treatment:<br>1. Vital signs<br>2. Physical examination<br>3. AEs<br>4. Laboratory parameters