Trials / Active Not Recruiting
Active Not RecruitingNCT05505916
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
An Open-label Extension Trial to Evaluate the Long-term Safety 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
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- KalVista Pharmaceuticals, Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KVD900 600 mg | KVD900 Tablet 600 mg (2 x 300 mg) |
| DRUG | KVD900 300 mg | KVD900 Tablet 300 mg |
Timeline
- Start date
- 2022-10-24
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2022-08-18
- Last updated
- 2026-02-18
Locations
71 sites across 23 countries: United States, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Romania, Saudi Arabia, Slovakia, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05505916. Inclusion in this directory is not an endorsement.