drugset / Trial / NCT03249480

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

NCT03249480

Phase 4 Unknown 900 enrolled Changchun GeneScience Pharmaceutical Co., Ltd. Anhui Provincial Children's Hospital · collabBeijing Children's Hospital · collabChildren's Hospital of Hebei Province · collabChildren's Hospital of Soochow University · collabChina-Japan Friendship Hospital · collabDalian Children's Hospital · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Kunming Medical University · collabFuzhou Children s Hospital · collabHenan Provincial People's Hospital · collabHunan Children's Hospital · collabKunming Children's Hospital · collabMaternal and Child Health Hospital of Guangxi Zhuang Autonomous Region · collabNanjing Children's Hospital · collabPeking University Third Hospital · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabShenzhen Children's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe First Affiliated Hospital of Henan University of Traditional Chinese Medicine · collabThe First People's Hospital of Yunnan · collabThe Second Affiliated Hospital of Kunming Medical University · collabThe Second Hospital of Hebei Medical University · collabTianjin Medical University General Hospital · collabUnion Hospital of Tongji Medical College of HUST · collabWuhan Children's Hospital · collabWuxi Women's & Children's Hospital · collabXian Children's Hospital · collabXuzhou Children's Hopspital · collabZhengzhou Children's Hospital, China · collab
NaSingle-groupOpen-labelTreatment

Summary

To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

Timeline

Start
2015-01
Primary completion
2017-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-somatropin Protein / enzyme biologic 0.1 mg/kg
Subject PEG-somatropin Protein / enzyme biologic 0.2 mg/kg

Indications