RecruitingPhase 3NCT06926491
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Sponsor
Kyowa Kirin Co., Ltd.
Enrollment
6 participants
Start Date
Dec 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 3 YearsMax Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- 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.
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Interventions
DRUGKK8398
KK8398 will be administered.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06926491
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