Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia(AOBA Study)
Recruiting
Phase 3
Interventional Study
Achondroplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 6 (estimated)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
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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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Patients who have been diagnosed with achondroplasia through genetic testing.
Exclusion Criteria:
1. …
Contacts