drugset / Trial / NCT03255694
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
Phase 2
Active not recruiting
360 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Affiliated Hospital of Jiangnan University · collabBeijing Children's Hospital · collabChildren's Hospital of Fudan University · collabChildren's Hospital of Soochow University · collabHunan Children's Hospital · collabJiangxi Province Children's Hospital · collabShanghai Children's Hospital · collabThe Children's Hospital of Zhejiang University School of Medicine · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe First Hospital of Jilin University · collabTongji Hospital · collabWuxi Women's & Children's Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.
Timeline
- Start
- 2017-05-12
- Primary completion
- 2030-06
- Completion
- 2030-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-somatropin | Protein / enzyme biologic | 0.2 mg/kg | — |
Indications
No indication recorded.