Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases|
- Adverse events [ Time Frame: During infusion or within 72 hours after end of infusion ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]
- Vital signs [ Time Frame: during each treatment ] [ Designated as safety issue: Yes ]
- laboratory parameters (hematology, clinical chemistry, direct Coombs test and urin analysis) [ Time Frame: at each treatment date (every three to four weeks) ] [ Designated as safety issue: Yes ]
- Assessment of viral safety [ Time Frame: Every three months ] [ Designated as safety issue: Yes ]
- Pre-next-dose levels of serum total IgG [ Time Frame: before each treatment ] [ Designated as safety issue: No ]
- Pre-next-dose levels of IgG subclasses (IgG1, IgG2, IgG3, IgG4) and pre-next-dose levels of specific antibodies against defined infectious agents [ Time Frame: before treatement 10 and 13 (of 13 or 17 treatments) and at the end ] [ Designated as safety issue: No ]
- Therapeutic efficacy (number of infections, number of missed days at school/ work, number of hospitalisation days, and use of antibiotics) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: Octagam 10%||
Drug: Octagam 10%
300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
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 Octagam 5%.
The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.