A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
Achondroplasia
About this trial
This is an interventional treatment trial for Achondroplasia focused on measuring Achondroplasia
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Recombinant human growth hormone
Recombinant human growth hormone Injection (15IU/5mg/3ml/bottle);0.05 mg/kg/d by subcutaneous injection for 52 weeks