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

Recruiting now · Phase 3

Conditions studied: Achondroplasia

In brief

This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia

Key facts

Study ID

NCT06926491

Run by

Kyowa Kirin Co., Ltd.

People needed

6

Starts

2024-12-01

Expected to finish

2031-05-31

Last updated by the study team

2025-04-29

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.
• 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.

Where it is running

• Aichi Children's Health and Medical Center — Ōbu, Aichi-ken, Japan (enrolling)
• Osaka University Hospital — Suita, Osaka, Japan (enrolling)
• Osaka Women's and Children's Hospital — Waizumi, Osaka, Japan (enrolling)
• Tokyo Metropolitan Children's Medical Center — Fuchū, Tokyo, Japan (enrolling)
• Tottori University Hospital — Yonago, Tottori, Japan (enrolling)
• Niigata University Medical and Dental Hospital — Niigata, Japan (enrolling)
• Okayama University Hospital — Okayama, Japan (enrolling)
• ISEIKAI International General Hospital — Osaka, Japan (enrolling)
• Osaka City General Hospital — Osaka, Japan (enrolling)

Full record on ClinicalTrials.gov

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