Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
NCT06467084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-01-23
Summary
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
Conditions
Interventions
- DRUG
-
KVD900 150 mg
KVD900 Tablet 150 mg (2 x 75 mg)
- DRUG
-
KVD900 300 mg
KVD900 Tablet 300 mg (1 x 300 mg)
- DRUG
-
KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Sponsors & Collaborators
-
KalVista Pharmaceuticals, Ltd.
lead INDUSTRY
Principal Investigators
-
Study Director · KalVista Pharmaceuticals, Ltd.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-24
- Primary Completion
- 2026-01-15
- Completion
- 2026-01-15
- FDA Drug
- Yes
Countries
- United States
- Canada
- France
- Germany
- Israel
- Italy
- Japan
Study Locations
More Related Trials
-
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
NCT02282163 ·Status: TERMINATED ·Phase: PHASE3
-
Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age
NCT02609919 ·Status: COMPLETED
-
Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy
NCT02041780 ·Status: COMPLETED ·Phase: NA
-
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
NCT00162045 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent
NCT02084628 ·Status: TERMINATED ·Phase: PHASE3
-
European and North Indian Cohort of KaWasaki dIsease
NCT06305611 ·Status: RECRUITING
-
Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
NCT05734794 ·Status: RECRUITING ·Phase: PHASE3
-
Phase 4 Paediatric Study to Evaluate Sonazoid Safety and Efficacy for Contrast-Enhanced Ultrasound Liver Imaging
NCT06639828 ·Status: RECRUITING ·Phase: PHASE4
-
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age
NCT05871970 ·Status: RECRUITING ·Phase: PHASE2
-
A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1
NCT00853580 ·Status: COMPLETED ·Phase: PHASE2
-
Ultrasound Method to Measure Fibrosis of the Liver in Children
NCT02086708 ·Status: TERMINATED ·Phase: NA
-
Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
NCT02752191 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
NCT04783675 ·Status: COMPLETED ·Phase: PHASE2
-
KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP
NCT03474991 ·Status: COMPLETED ·Phase: PHASE3
-
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
NCT02117713 ·Status: COMPLETED ·Phase: PHASE2
-
Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics
NCT03606980 ·Status: TERMINATED ·Phase: PHASE2
-
Establishing the Clinical Utility of First StepDx PLUS and NextStepDx PLUS Study
NCT02414438 ·Status: COMPLETED ·Phase: NA
-
Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children
NCT04996485 ·Status: UNKNOWN ·Phase: PHASE4
-
Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences
NCT04741412 ·Status: COMPLETED
-
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
NCT01092754 ·Status: COMPLETED ·Phase: PHASE4
-
Ceftriaxone in Non-neutropenic Fever
NCT01225718 ·Status: COMPLETED
-
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
NCT06417320 ·Status: RECRUITING ·Phase: PHASE4
-
miRNA in Pediatric Gastritis
NCT07300787 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
NCT06004596 ·Status: COMPLETED ·Phase: NA
-
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
NCT03233126 ·Status: COMPLETED ·Phase: PHASE3