CompletedPhase 3

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)

United States136 participantsStarted 2022-02-22

Plain-language 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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. has had at least 2 documented HAE attacks within 3 months prior to screening or randomization; or
✓. is a completer of the KVD824-201 trial within 3 months prior to randomization and meets all other entry criteria to enroll in KVD900-301

Exclusion criteria

✕. Alanine aminotransferase (ALT) \>2x upper limit of normal (ULN)
✕. Aspartate aminotransferase (AST) \>2x ULN
✕. Bilirubin direct \>1.25x ULN
✕. International normalized ratio (INR) \>1.2
✕. Clinically significant hepatic impairment defined as a Child-Pugh B or C

What they're measuring

Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C)

Timeframe: Within 12 hours of the first investigational medicinal product (IMP) administration.

Trial details

NCT IDNCT05259917

SponsorKalVista Pharmaceuticals, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

Results submitted2024-06-12

View on ClinicalTrials.gov More Hereditary Angioedema trials