KONFIDENT-S
Research type
Research Study
Full title
An Open-label Extension Trial to Evaluate the Long-term Safety 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 I
IRAS ID
1004964
Contact name
Katie Leathard
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd
Eudract number
2021-001176-42
ISRCTN Number
ISRCTN98539585
Clinicaltrials.gov Identifier
Research summary
This trial is being funded by KalVista Pharmaceuticals.
Up to 150 patients (including a minimum of 12 adolescents) with HAE Type I or II are planned to be enrolled in this global trial for KVD900, an oral plasma kallikrein inhibitor which is designed to stop the beginning steps to make more plasma kallikrein, which lowers the amount of blood vessel swelling and helps treat HAE. Patients may take up to two 600 mg doses of KVD900 to treat an HAE attack. This trial is open label, which means there is no placebo. Participation will last up to 2 years. The primary objective is to assess the safety of long-term administration of KVD900 in adolescent and adult patients with hereditary angioedema type I or II.
Eligible patients 12 years of age or older will undergo an in-clinic screening assessment for trial inclusion. For patients who roll over following participation in the KVD900-301 trial, this visit may be the same visit as the Final Visit in the KVD900-301 trial if the Final Visit in that trial is within 30 days of enrolment in KVD900-302. If the Final Visit of KVD900-301 was >30 days prior to rollover, the patient must complete a separate Enrolment Visit.
Participants will be asked to attend in-clinic and televisits. Trial procedures will include physical examinations, vital signs, Electrocardiogram, blood samples, completion of ediary and questionnaires. Use of KVD900 as a short-term prophylactic will be allowed on a case-by-case basis.
There is an optional pharmacokinetic sub-trial in adolescents (ages 12-17), requiring the collection of three blood samples within the first six hours that follow the HAE attack that has been treated with the trial drug.REC name
HSC REC B
REC reference
22/NI/0124
Date of REC Opinion
5 Sep 2022
REC opinion
Further Information Favourable Opinion