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Clinical Trials in Japan / NCT06926491
Recruiting Phase 3

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

NCT06926491 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2024-12-01
Last updated
2025-04-29

Condition(s) studied

Achondroplasia

Investigational drug(s) / intervention(s)

KK8398

KK8398: KK8398 will be administered.

Study 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

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Patients who have been diagnosed with achondroplasia through genetic testing. Exclusion Criteria: 1. Patients who meet the criteria for a certain height determined by age and gender in the "Growth Chart for Patients with Achondroplasia" at the time of the pre-registration examination 2. Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination. 3. Patients who have had previous osteotomy or who are scheduled to undergo osteotomy or epiphyseal growth inhibition during the study period. Epiphyseal growth inhibition in which the plate was removed more than 26 weeks prior to the pre-registration examination will not be excluded if the patient has completely healed without sequelae, based on the judgment of the investigator or sub-investigator.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Aichi Children's Health and Medical Center Ōbu Aichi-ken Recruiting
Osaka University Hospital Suita Osaka Recruiting
Osaka Women's and Children's Hospital Waizumi Osaka Recruiting
Tokyo Metropolitan Children's Medical Center Fuchū Tokyo Recruiting
Tottori University Hospital Yonago Tottori Recruiting
Niigata University Medical and Dental Hospital Niigata Japan Recruiting
Okayama University Hospital Okayama Japan Recruiting
ISEIKAI International General Hospital Osaka Japan Recruiting
Osaka City General Hospital Osaka Japan Recruiting

More Kyowa Kirin Co., Ltd. trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06926491 on ClinicalTrials.gov ↗ ← All trials in Japan