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NCT05505916 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Hereditary Angioedema, sponsored by KalVista Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
- 20
- Study locations
NCT05505916: Active Phase 3 study of Hereditary Angioedema, sponsored by KalVista Pharmaceuticals.
NCT05505916 is a Phase 3 study of Hereditary Angioedema that is active but no longer recruiting, run by KalVista Pharmaceuticals. The registered enrollment target is 145 participants, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05505916, a Phase 3 study of Hereditary Angioedema, is active but no longer recruiting, sponsored by KalVista Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG KVD900 600 mg
- DRUG KVD900 300 mg
Study Locations (20)
California
- KalVista Investigative Site - San Diego
- KalVista Investigative Site - San Diego
- KalVista Investigative Site - Santa Monica
Colorado
- KalVista Investigative Site - Centennial
- KalVista Investigative Site - Colorado Springs
Ohio
- KalVista Investigative Site - Cincinnati
- KalVista Investigative Site - Toledo
Arizona
- KalVista Investigative Site - Scottsdale
Arkansas
- KalVista Investigative Site - Little Rock
Indiana
- KalVista Investigative Site - Evansville
Kansas
- KalVista Investigative Site - Overland Park
Kentucky
- KalVista Investigative Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT05505916 still lists
NCT05505916 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (123% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions - of which KVD900 600 mg is the first listed.
NCT05505916 names 20 study sites across 16 states, led by California, Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT05505916 about?
NCT05505916 is a clinical study titled "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)". 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.
What is the current status of trial NCT05505916?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2022-10-24. Estimated completion is 2026-06-30.
What conditions does trial NCT05505916 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT05505916?
The interventions under investigation include: KVD900 600 mg (DRUG), KVD900 300 mg (DRUG).
Who is sponsoring clinical trial NCT05505916?
This trial is sponsored by KalVista Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05505916 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hereditary Angioedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05505916's enrollment target sits among peer trials
145 3rd of 14 higher than 12 of 14 other Hereditary Angioedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hereditary Angioedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
RECRUITING · Phase 3
-
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
ACTIVE NOT RECRUITING · Phase 3
-
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
ACTIVE NOT RECRUITING · Phase 3
-
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
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-
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
COMPLETED · Phase 3
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OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
COMPLETED · Phase 3
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