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Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
Details
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2009-12 |
Conditions
- Small for Gestational Age Infant
Interventions
- Somatropin Injection low dose group
- Somatropin Injection high dose group
Primary outcomes
- Height standard deviation score for chronological age (Ht SDSCA) — 26 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) - Height standard deviation score for chronological age (Ht SDSCA) — 52 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) - Height standard deviation score for chronological age (Ht SDSCA) — 78 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) - Height standard deviation score for chronological age (Ht SDSCA) — 104 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
Countries
China