Overview
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
Eligibility
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