NCT01786902
Completed
Phase 3
Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
Overview
- Phase
- Phase 3
- Intervention
- DA-3002
- Conditions
- Idiopathic Short Stature
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 70
- Primary Endpoint
- Annualized Height Velocity(cm/Year) After 26 Weeks
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronological Age ≥ 4
- •Bone Age \<11 (for girls) and \<13 (for boys)
- •Height \<3rd percentile for age
- •normal thyroid function
Exclusion Criteria
- •endocrine and/or metabolic disorders
- •growth failure caused by other disorders
- •previous use of drugs that could interfere with Growth Hormone treatment
Arms & Interventions
DA-3002 Treatment group
1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
Intervention: DA-3002
Outcomes
Primary Outcomes
Annualized Height Velocity(cm/Year) After 26 Weeks
Time Frame: 26 weeks
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
Secondary Outcomes
- Changes in Height Standard Deviation Score After 26 Weeks(26 weeks)
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