ISRCTN63491981
Completed
N/A
Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in primary immunodeficiency diseases
Octapharma AG (Switzerland)0 sites45 target enrollmentDecember 18, 2008
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Primary immunodeficiency diseases (PID)
- Sponsor
- Octapharma AG (Switzerland)
- Enrollment
- 45
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age of greater than or equal to 2 years and less than or equal to 75 years, either sex
- •2\. For minor patients, above a minimum weight based on the amount of blood required for testing: per individual, the trial\-related blood loss (including any losses in the manoeuvre) should not exceed 3% of the total blood volume during a period of four weeks and should not exceed 1% at any single time (the total volume of blood is estimated at 80 ml/kg body weight)
- •3\. Confirmed diagnosis of primary immunodeficiency as stated by the World Health Organization and requiring immunoglobulin replacement therapy. The exact type of PID should be recorded.
- •4\. Previously treated with commercial Octagam® 5% every 21 \- 28 days for at least six infusion intervals at a constant dose of 300 \- 600 mg/kg body weight
- •5\. Availability of the IgG trough levels of the two previous infusions before enrolment, and maintenance of at least 5\.5 g/L in the trough levels of these two infusions
- •6\. Negative result on a pregnancy test (human chorionic gonadotropin \[HCG]\-based assay in blood or urine) for women of child\-bearing potential and use of a reliable method of contraception for the duration of the study
- •7\. For adult patients: freely given written informed consent. For minor patients: freely given written informed consent from both parents/legal guardians and written informed assent from the child/adolescent greater than or equal to 8 years of age according to his/her age and capacity of understanding
- •8\. Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study
Exclusion Criteria
- •1\. Acute infection requiring intravenous antibiotic treatment within two weeks before screening
- •2\. Known history of adverse reactions to IgA in other products
- •3\. Exposure to blood or any blood product or derivative, other than commercially available Octagam® 5%, within the past 3 months
- •4\. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product, such as maltose
- •5\. Requirement of any routine premedication for IGIV infusion
- •6\. History of congenital impairment of pulmonary function
- •7\. Severe liver function impairment (alanine aminotransferase \[ALAT] 3 x greater than normal value)
- •8\. Severe renal function impairment (creatinine greater than 120 µmol/L), or predisposition for acute renal failure (e.g. any degree of pre\-existing renal insufficiency or routine treatment with known nephritic drugs)
- •9\. History of autoimmune haemolytic anaemia
- •10\. History of diabetes mellitus
Outcomes
Primary Outcomes
Not specified
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