Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
NCT ID: NCT06926491
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
6 participants
INTERVENTIONAL
2024-12-01
2031-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KK8398
KK8398
KK8398 will be administered.
Interventions
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KK8398
KK8398 will be administered.
Eligibility Criteria
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Inclusion Criteria
2. Patients who have been diagnosed with achondroplasia through genetic testing.
Exclusion Criteria
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.
3 Years
18 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yu Sato
Role: STUDY_DIRECTOR
Kyowa Kirin Co., Ltd.
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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jRCT2031240562
Identifier Type: REGISTRY
Identifier Source: secondary_id
8398-001
Identifier Type: -
Identifier Source: org_study_id
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