A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

June 30, 2030

Study Completion Date

June 30, 2030

Conditions
Dwarfism
Interventions
DRUG

PEG-somatropin

After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.

Trial Locations (12)

Unknown

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing

Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Wuhan

Hunan Children's Hospital, Changsha

Children's Hospital of Soochow University, Naning

The First Affiated Hospital of Nanjing Medical Universit, Nanjing

Affiliated Hospital of Jiangnan University, Wuxi

Wuxi Children's Hospital, Wuxi

Jiangxi Provincial Children's Hospital, Nanchang

The First Hospital of Jilin University, Changchun

The Children's Hospital of Zhejiang University School of Medicine, Hangzhou

Shanghai Children's Hospital of Fudan University, Shanghai

Shanghai Children's Hospital, Shanghai

All Listed Sponsors
collaborator

Tongji Hospital

OTHER

collaborator

The First Hospital of Jilin University

OTHER

collaborator

Affiliated Hospital of Jiangnan University

OTHER

collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

collaborator

Shanghai Children's Hospital

OTHER

collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

collaborator

Children's Hospital of Fudan University

OTHER

collaborator

Jiangxi Province Children's Hospital

OTHER

collaborator

Hunan Children's Hospital

OTHER_GOV

collaborator

Beijing Children's Hospital

OTHER

collaborator

Children's Hospital of Soochow University

OTHER

collaborator

Wuxi Women's & Children's Hospital

OTHER

lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY