NCT04208412

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 Randomized, Double-blind, Placebo-controlled, Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: KalVista Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	KVD900	KVD900 tablet 600 mg
OTHER	Placebo	KVD900-matched Placebo Tablet

Timeline

• Start date: 2019-07-02
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2019-12-23
• Last updated: 2025-05-02
• Results posted: 2023-02-08

Locations

25 sites across 10 countries: United States, Austria, Czechia, Germany, Hungary, Italy, Netherlands, North Macedonia, Poland, United Kingdom

Regulatory

• FDA-regulated drug study