Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Children's Hospital of Fudan University
Tongji Hospital
Conditions:
Achondroplasia
Eligibility:
All Genders
2-10 years
Phase:
PHASE4
Brief Summary
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 2-10 years old;
- In Tanner I stage;
- ACH, documented and confirmed by genetic testing;
- Short stature;
- Ambulatory and able to stand or walk without assistance;
- Parent(s) or guardian(s) consent；
- Had never been treated with growth hormone
- Exclusion criteria:
- Short stature condition other than ACH;
- Evidence of growth plate closure (proximal tibia, distal femur);
- Had a fracture of the long bones within 6 months prior to screening;
- Planned or expected bone-related surgery;
- Chronic diseases condition that affect bone metabolism and weight;
- Severe intracranial hypertension
Exclusion
Key Trial Info
Start Date :
September 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05353192
Start Date
September 23 2022
End Date
February 1 2025
Last Update
February 28 2023
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102