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NCT04208412 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
A Phase 2 study of Hereditary Angioedema, sponsored by KalVista Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT04208412: Completed Phase 2 study of Hereditary Angioedema, sponsored by KalVista Pharmaceuticals.
NCT04208412 is a Phase 2 study of Hereditary Angioedema that has completed, run by KalVista Pharmaceuticals. The registered enrollment target is 84 participants, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04208412, a Phase 2 study of Hereditary Angioedema, has completed, sponsored by KalVista Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
Primary Outcome
The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous \[iv\] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred \>12 hours following study drug.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG KVD900
Study Locations (20)
Other
- KalVista Investigative Site - Vienna
- KalVista Investigative Site - Brno
- KalVista Investigative Site - Hradec Králové
- KalVista Investigative Site - Pilsen
- KalVista Investigative Site - Berlin
- KalVista Investigative Site - Frankfurt
- KalVista Investigative Site - Mörfelden-Walldorf
- KalVista Investigative Site - Budapest
- KalVista Investigative Site - Milan
- KalVista Investigative Site - Milano-2
- KalVista Investigative Site - Padua
- KalVista Investigative Site - Amsterdam
- KalVista Investigative Site - Skopje
- KalVista Investigative Site - Krakow
Arizona
- KalVista Investigative Site - Scottsdale
Colorado
- KalVista Investigative Site - Centennial
Maryland
- KalVista Investigative Site - Chevy Chase
Ohio
- KalVista Investigative Site - Cincinnati
Texas
- KalVista Investigative Site - Dallas
Washington
- KalVista Investigative Site - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2020-12-08 |
| Phase | Phase 2 |
What the finished NCT04208412 record still lists
NCT04208412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04208412 names 20 study sites across 7 states, led by Other, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT04208412 about?
NCT04208412 is a clinical study titled "A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II". This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
What is the current status of trial NCT04208412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2019-07-02. Estimated completion is 2020-12-08.
What conditions does trial NCT04208412 study?
This clinical trial studies the following conditions: Hereditary Angioedema.
What interventions are being tested in trial NCT04208412?
The interventions under investigation include: Placebo (OTHER), KVD900 (DRUG).
Who is sponsoring clinical trial NCT04208412?
This trial is sponsored by KalVista Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04208412 being conducted?
This trial has 20 study locations across Arizona, Colorado, Maryland, Ohio, Texas. 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 NCT04208412's enrollment target sits among peer trials
84 6th of 14 higher than 9 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
-
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-
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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)
ACTIVE NOT RECRUITING · Phase 3
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