Vertex Pharmaceuticals
This sponsor has funded 4 studies across 5 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 4270 | Finalised | EU RMP category 1 | An Observational Study to Evaluate the Long-term Safety of Ivacaftor in Patients With Cystic Fibrosis | Yes | Yes |
| 15943 | Finalised | EU RMP category 1 | An Observational Study to Evaluate the Utilisation Patterns and Long-term Effects of Lumacaftor and Ivacaftor Combination Therapy in Patients With... | Yes | Yes |
| 30550 | Finalised | EU RMP category 3 | Utilisation Patterns and Real-World Effects of Tezacaftor and Ivacaftor Combination Therapy (TEZ/IVA) in Patients With Cystic Fibrosis (CF) | Yes | Yes |
| 43022 | Ongoing | EU RMP category 3 | Real-World Effects and Utilisation Patterns of Elexacaftor, Tezacaftor, and Ivacaftor Combination Therapy (ELX/TEZ/IVA) in Patients with Cystic... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Vertex Pharmaceuticals
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
Vertex Pharmaceuticals
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
Vertex Pharmaceuticals
5 Study countries specified are the following:
- France
- Germany
- Ireland
- United Kingdom
- United States