KONFIDENT
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II
IRAS ID
1004998
Contact name
Katie Leathard
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd
Eudract number
2021-001226-21
ISRCTN Number
ISRCTN14762022
Clinicaltrials.gov Identifier
Research summary
This trial is being funded by KalVista Pharmaceuticals.
Approximately 114 patients with HAE Type I or II will be enrolled into the trial. Patients will be enrolled from several different countries. This study is being done to understand how well KVD900 300mg or KVD900 600mg works against placebo to bring relief from an attack of HAE. In this study every patient will treat one attack with 300mg KVD900, one attack with 600mg of KVD900 and one attack with placebo. The order the patients use the treatments will be assigned by chance. During each treated attack the patients will answer several questions regarding their symptoms during the course of the treatment.
Participants will be asked to attend the site approximately for 2 visits and have 4 tele visits. It is anticipated that it will take approximately 25 weeks for each patient to complete the screening assessments and treat 3 eligible attacks. In addition to the questions regarding the HAE attack symptoms and effectiveness of the treatments, patients will undergo routine safety assessments, such as laboratory assessments and physicals.
Summary of Results:-
In this clinical study, researchers wanted to see how well 1 or 2 doses of KVD900 300 mg or KVD900 600 mg worked to bring relief from an HAE attack when compared to a placebo. Results of this clinical study showed that treatment with KVD900 (300 mg or 600 mg) improved
(shortened) the time to the beginning of HAE symptom relief compared to placebo.More HAE attacks started to show signs of symptom relief within 12 hours of the first dose of the study drug(s) in the KVD900 treatment groups (300 mg and 600 mg) than the placebo group.
Findings from this clinical study helped researchers learn about the effectiveness of 2 different doses of KVD900 (300 mg and 600 mg) given as an oral tablet in adolescents and adults with HAE. KVD900 helped to improve the symptom relief during an HAE attack without serious safety issues. KVD900 300 mg and 600 mg was generally well-tolerated and side effects reported in the clinical study were about the same in the KVD900 groups and the placebo group.
REC name
West of Scotland REC 1
REC reference
22/WS/0042
Date of REC Opinion
16 May 2022
REC opinion
Further Information Favourable Opinion