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Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia(AOBA Study)
Sponsor: Kyowa Kirin Co., Ltd.
Summary
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia
Official title: A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2024-12-01
Completion Date
2031-05-31
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
KK8398
KK8398 will be administered.
Locations (9)
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Osaka University Hospital
Suita, Osaka, Japan
Osaka Women's and Children's Hospital
Waizumi, Osaka, Japan
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Niigata University Medical and Dental Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
ISEIKAI International General Hospital
Osaka, Japan
Osaka City General Hospital
Osaka, Japan