drugset / Trial / NCT05055258
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
Timeline
- Start
- 2021-11-18
- Primary completion
- 2022-10-27
- Completion
- 2022-10-27
Outcome
Missed primary endpoint
Stopped: “Terminated by Sponsor due to adverse events reported”
registry analysis (superiority test); 300 mg KVD824 BID vs Placebo to KVD824 BID; p = 0.2862 NCT05055258 ↗
registry analysis (superiority test); 600 mg KVD824 BID vs Placebo to KVD824 BID; p = 0.0918 NCT05055258 ↗
registry analysis (superiority test); 900 mg KVD824 BID vs Placebo to KVD824 BID; p = 0.3685 NCT05055258 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FENIRALSTAT | Small molecule | 300 mg | Oral |
| Subject | FENIRALSTAT | Small molecule | 600 mg | Oral |
| Subject | FENIRALSTAT | Small molecule | 900 mg | Oral |