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Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
This is a Phase 3, open-label, roll-over study to demonstrate the continued hepatic and non-hepatic safety and renal efficacy of lixivaptan in participants with ADPKD who previously experienced abnormal liver chemistry test results while treated with tolvaptan, were permanently discontinued from the drug for that reason, and subsequently completed study PA-ADPKD-303, the open-label lead-in study with lixivaptan.
Details
| Lead sponsor | Palladio Biosciences |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | Thu Feb 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jul 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Polycystic Kidney Disease, Adult
Interventions
- Lixivaptan
Countries
United States