NCT05511922CompletedPhase 3
A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
KalVista Pharmaceuticals, Ltd.61 sites in 14 countries11 target enrollmentStarted: October 24, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 11
- Locations
- 61
- Primary Endpoint
- Pharmacokinetics - Tmax
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts 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-
- •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.
Arms & Interventions
KVD900 600 mg
Experimental
Intervention: KVD900 600 mg (Drug)
Experimental: KVD900 300 mg
Experimental
Intervention: Drug: KVD900 300 mg (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics - Tmax
Time Frame: Up to 6 hours after IMP administration
Pharmacokinetics - Cmax
Time Frame: Up to 6 hours after IMP administration
Pharmacokinetics - AUC
Time Frame: Up to 6 hours after IMP administration
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (61)
Loading locations...
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