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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)

NCT05259917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-05-02

Study results available
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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

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)

Sponsors & Collaborators

  • KalVista Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Study Director · KalVista Pharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259917 on ClinicalTrials.gov