Recruiting NCT06926491
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KK8398.
- Who it may be relevant to
- Registry conditions: Achondroplasia. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
Overview
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia
Interventions
- Drug KK8398
KK8398 will be administered.
Primary outcome measures
- Change from baseline in annualized height velocity [Time frame: Pre-dose, Week 52]
Secondary outcome measures (1)
- Height Z-score using growth tables in patients with achondroplasia and the change from baseline [Time frame: Pre-dose, Week 52]
Eligibility criteria
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 9 centers
- Aichi Children's Health and Medical Center — Ōbu
- Osaka University Hospital — Suita
- Osaka Women's and Children's Hospital — Waizumi
- Tokyo Metropolitan Children's Medical Center — Fuchū
- Tottori University Hospital — Yonago
- Niigata University Medical and Dental Hospital — Niigata
- Okayama University Hospital — Okayama
- ISEIKAI International General Hospital — Osaka
- … and 1 more center
Identifiers
NCT: NCT06926491 · 8398-001 · jRCT2031240562