Orchard Therapeutics
This sponsor has funded 3 studies across 27 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 15795 | Ongoing | Adenosine Deaminase Severe Combined Immunodeficiency (ADA-SCID) Registry for Patients Treated with Strimvelis (or GSK2696273) Gene Therapy: Long-Term... | No | No |
| 19951 | Finalised | Evaluation of referring HCPs’ and parents’/carers’ understanding of specific risks associated with Strimvelis™ treatment (STRIM-001) | Yes | No |
| 48374 | Ongoing | Long-term efficacy and safety follow-up of MLD patients treated with atidarsagene autotemcel (LongTERM-MLD) | No | No |
PAS by Risk Management Plan (RMP) requirement
Orchard Therapeutics
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
Orchard Therapeutics
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
Orchard Therapeutics
27 Study countries specified are the following:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- United Kingdom