Status:
RECRUITING
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Achondroplasia
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2031
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06926491
Start Date
December 1 2024
End Date
May 31 2031
Last Update
April 29 2025
Active Locations (9)
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1
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
2
Osaka University Hospital
Suita, Osaka, Japan
3
Osaka Women's and Children's Hospital
Waizumi, Osaka, Japan
4
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan