jRCT2031240562RecruitingNot Applicable
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients with Achondroplasia (AOBA study)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 6
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized Controlled Trial
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 3age old over to 18age old not (—)
- Sex
- All
Inclusion Criteria
- •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 Criteria
- •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 analogat 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.
Outcomes
Primary Outcomes
-
Change from Baseline in annualized height velocity
Secondary Outcomes
No secondary outcomes reported
Investigators
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