Trials / Completed
CompletedNCT05259917
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- KalVista Pharmaceuticals, Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo to KVD900 Tablet |
| DRUG | KVD900 600 mg | KVD900 Tablet 600 mg (2 x 300 mg) |
| DRUG | KVD900 300 mg | KVD900 Tablet 300 mg (1 x 300 mg) |
Timeline
- Start date
- 2022-02-22
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2022-03-02
- Last updated
- 2025-05-02
- Results posted
- 2024-07-19
Locations
66 sites across 21 countries: United States, Australia, Bulgaria, Canada, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Puerto Rico, Romania, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05259917. Inclusion in this directory is not an endorsement.