Actively Recruiting
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
Led by Kyowa Kirin Co., Ltd. · Updated on 2025-04-29
6
Participants Needed
9
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 2.5 and 17.5 years old at provisional registration
- Patients who meet certain Tanner stage and bone age criteria
- Patients diagnosed with achondroplasia by genetic testing
You will not qualify if you...
- Patients who meet certain height criteria based on age and gender on the Achondroplasia Growth Chart at pre-registration
- Patients who received r-hGH or CNP analogue treatment within a certain period before pre-enrollment
- Patients who had or plan to have osteotomy or epiphyseal growth inhibition during the study, except if the growth plate surgery was over 26 weeks before pre-registration and fully healed without aftereffects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Actively Recruiting
2
Osaka University Hospital
Suita, Osaka, Japan
Actively Recruiting
3
Osaka Women's and Children's Hospital
Waizumi, Osaka, Japan
Actively Recruiting
4
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Actively Recruiting
5
Tottori University Hospital
Yonago, Tottori, Japan
Actively Recruiting
6
Niigata University Medical and Dental Hospital
Niigata, Japan
Actively Recruiting
7
Okayama University Hospital
Okayama, Japan
Actively Recruiting
8
ISEIKAI International General Hospital
Osaka, Japan
Actively Recruiting
9
Osaka City General Hospital
Osaka, Japan
Actively Recruiting
Research Team
K
Kyowa Kirin Co., Ltd.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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