CSL Behring
This sponsor has funded 4 studies across 20 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 6040 | Ongoing | Privigen® use and haemolytic anaemia in adults and children and the Privigen® safety profile in children with CIDP - an observational hospital-based... | Yes | No |
| 8472 | Finalised | An observational cohort study of the risk of thromboembolic events among adult patients treated with KCENTRA® compared with plasma for urgent reversal... | No | No |
| 48683 | Planned | World Federation of Hemophilia Gene Therapy Registry (WFH GTR) | No | No |
| 106066 | Planned | An Observational Post-authorization Long-term Follow-up Study to Characterize the Effectiveness and Safety of HEMGENIX® (Etranacogene Dezaparvovec) in... | No | No |
PAS by Risk Management Plan (RMP) requirement
CSL Behring
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
CSL Behring
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
CSL Behring
20 Study countries specified are the following:
- Australia
- Austria
- Belgium
- Canada
- Denmark
- France
- Germany
- Greece
- Ireland
- Israel
- Italy
- Japan
- Netherlands
- Saudi Arabia
- Spain
- Sweden
- Switzerland
- Türkiye
- United Kingdom
- United States