Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 11
Healthy Volunteers: f
View:
• Male or female patients 2 to 11 years of age.
• Confirmed diagnosis of HAE Type I or II.
• For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
• Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
• Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
• Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).
Locations
United States
Alabama
KalVista Investigative Site
RECRUITING
Birmingham
Arizona
KalVista Investigative Site
RECRUITING
Scottsdale
California
KalVista Investigative Site
RECRUITING
San Diego
KalVista Investigative Site
RECRUITING
Santa Monica
Indiana
KalVista Investigative Site
RECRUITING
Evansville
Maryland
KalVista Investigative Site
RECRUITING
Wheaton
Missouri
KalVista Investigative Site
RECRUITING
St Louis
Ohio
KalVista Investigative Site
COMPLETED
Toledo
Pennsylvania
KalVista Investigative Site
COMPLETED
Hershey
Texas
KalVista Investigative Site
COMPLETED
Dallas
Other Locations
Canada
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Edmonton
France
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Lille
KalVista Investigative Site
COMPLETED
Marseille
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Paris
Germany
KalVista Investigative Site
COMPLETED
Frankfurt Am Main
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Israel
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Haifa
KalVista Investigative Site
COMPLETED
Petah Tikva
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Milan
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Padua
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Rome
Japan
KalVista Investigative Site
COMPLETED
Kawagoe
KalVista Investigative Site
ACTIVE_NOT_RECRUITING
Tokyo
Contact Information
Primary
KalVista Pharmaceuticals
clinicalstudies@kalvista.com
1 (857) 999-0075
Time Frame
Start Date:2024-06-24
Estimated Completion Date:2027-08-31
Participants
Target number of participants:48
Treatments
Other: 150 mg Dose Group
Patients will take a single 150 mg dose of KVD900.
Other: 300 mg Dose Group
Patients will take a single 300 mg dose of KVD900.
Other: 600 mg Dose Group
Patients will take a single 600 mg dose of KVD900.