Hereditary Angioedema
Conditions
Keywords
KONFIDENT-S, Sebetralstat
Brief summary
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
Interventions
DRUGKVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
DRUGDrug: KVD900 300 mg
KVD900 Tablet 300 mg
Sponsors
KalVista Pharmaceuticals, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial. * Patient is currently participating in KVD900-302. * Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable. * Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.
Exclusion criteria
* Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics - Cmax | Up to 6 hours after IMP administration |
| Pharmacokinetics - Tmax | Up to 6 hours after IMP administration |
| Pharmacokinetics - AUC | Up to 6 hours after IMP administration |
Countries
Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Japan, Netherlands, New Zealand, Romania, Slovakia, South Africa, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Director
KalVista Pharmaceuticals, Ltd.
Outcome results
None listed