A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:
• Patients who are between 2.5 and 17.5 years old of age at the time of provisional registration. Patients who meet certain criteria in terms of Tanner stage and bone age.
• Patients who have been diagnosed with achondroplasia through genetic testing.
Locations
Other Locations
Japan
Tokyo Metropolitan Children's Medical Center
RECRUITING
Fuchū
Niigata University Medical and Dental Hospital
RECRUITING
Niigata
Aichi Children's Health and Medical Center
RECRUITING
Ōbu
Okayama University Hospital
RECRUITING
Okayama
ISEIKAI International General Hospital
RECRUITING
Osaka
Osaka City General Hospital
RECRUITING
Osaka
Osaka University Hospital
RECRUITING
Suita
Osaka Women's and Children's Hospital
RECRUITING
Waizumi
Tottori University Hospital
RECRUITING
Yonago
Contact Information
Primary
Kyowa Kirin Co., Ltd.
clinical.info.jp@kyowakirin.com
+81-3-5205-7200
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2031-05-31
Participants
Target number of participants: 6
Treatments
Experimental: KK8398
Related Therapeutic Areas
Sponsors
Leads: Kyowa Kirin Co., Ltd.