Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
ConditionAchondroplasia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-18
SponsorKyowa Kirin Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KK8398
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov