Non-Interventional Study on the Tolerability and Efficacy of IVIG
- Conditions
- Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
- Interventions
- Biological: Octagam IVIG 5% or 10%Biological: Panzyga
- Registration Number
- NCT02303093
- Lead Sponsor
- Octapharma
- Brief Summary
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
- Detailed Description
A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Octagam Octagam IVIG 5% or 10% Patient receiving Octagam 5% or 10% IVIG Panzyga Panzyga Patient receiving panzyga
- Primary Outcome Measures
Name Time Method Adverse Drug Reactions up to one year Number of patients with adverse drug reactions
- Secondary Outcome Measures
Name Time Method Infection Occurrence Up to one year Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.
Trial Locations
- Locations (8)
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Octapharma Research Location
🇪🇸Madrid, Spain
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Octapharma Research Site
🇬🇧Stafford, United Kingdom
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Octapharma Research Center
🇫🇷Marseille, France