A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

July 31, 2023

Study Completion Date

July 31, 2023

Conditions
Pediatric Growth Hormone Deficiency
Interventions
DRUG

TJ101

TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety.

DRUG

NordiFlex

TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety.

Trial Locations (30)

430030

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

Unknown

Second Affiliated Hospital of Anhui Medical University, Hefei

Beijing Children's Hospital,Capital Medical University, Beijing

Children's Hospital, Capital Institute of Paediatrics, Beijing

Chongqing Three Gorges Central Hospital, Wanzhou

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

The Third Affiliated Hospital of Sun Yet-sen University, Guangzhou

Liuzhou Maternity and Children Healthcare Hospital, Liuzhou

Hainan Third People's Hospital, Sanya

Tangshan Women and Children's Hospital, Tangshan

Henan Children's Hospital, Zhengzhou

Wuhan Children's Hospital, Wuhan

Hunan Children's Hospital, Changsha

The First Affiliated Hospital of Nanhua University, Hengyang

Children's Hospital of Nanjing Medical University, Nanjing

Jiangsu Provincial Maternal and Child Health Hospital, Nanjing

Children's Hospital affiliated to Soochow University, Suzhou

Jiangxi Provincial Children's Hospital, Nanchang

Pingxiang Maternity and Child Care Hospital, Pingxiang

The First Bethune Hospital of Jilin University, Changchun

Shengjing Hospital of China Medical University, Shenyang

General Hospital of Ningxia Medical University, Yinchuan

Affiliated Hospital of Jining Medical College, Jining

Linyi Women and Children's Hospital, Linyi

Shanghai Children's Medical Center, Shanghai

Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai

Chengdu Women's and Children's Central Hospital, Chengdu

West China Second Hospital of Sichuan University, Chengdu

Taizhou First People's Hospital, Liuzhou

Ningbo Women & Children's Hospital, Ningbo

All Listed Sponsors
lead

TJ Biopharma Co., Ltd.

INDUSTRY

NCT04633057 - A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter