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RECRUITING
NCT06926491
PHASE3

Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia(AOBA Study)

Sponsor: Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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