drugset / Trial / NCT01342146
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Phase 2
Completed
101 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Capital Medical University · collabChildren's Hospital of Fudan University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabHuazhong University of Science and Technology · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-01
- Completion
- 2007-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Jintropin AQ | Unknown | 0.25 mg/kg | — |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 0.1 mg/kg | — |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 0.2 mg/kg | — |