Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Summary

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Conditions

• Growth Hormone Deficiency

Interventions

BIOLOGICAL

PEG-somatropin

High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

BIOLOGICAL

PEG-somatropin

Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• Guangzhou Women and Children's Medical Center

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Zhejiang Provincial Hospital of TCM

  collaborator OTHER

• Central South University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Shaoxing Second Hospital

  collaborator OTHER

• Changchun GeneScience Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Junfen Fu, PhD · The Children's Hospital of Zhejiang University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2017-06-30

Countries

• China

Study Locations