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

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.

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.

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Shanghai Children's Hospital

  collaborator OTHER

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

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Beijing Children's Hospital

  collaborator OTHER

• Children's Hospital of Soochow University

  collaborator OTHER

• Wuxi Women's & Children's Hospital

  collaborator OTHER

• Changchun GeneScience Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Xiaoping Luo · Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-12

Primary Completion

2030-06-30

Completion

2030-06-30

Countries

• China

Study Locations