Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature

Summary

The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.

This is a multicenter, randomized, open-label, dose-response trial, including a 52-week main phase and an ongoing safety extension phase continuing until reaching near-adult height (NAH) in China. Ninety-six growth hormone (GH)-treatment-naïve, non-GH-deficient, prepubertal short children born SGA were randomized in a 1:1 ration to receive weekly subcutaneous administration of Jintrolong 0.1 mg/kg/week or 0.2 mg/kg/week for 52 weeks. Children who completed the 52- week main phase proceeded to the extension phase, while Jintrolong was administered at an initial dose of 0.2 mg/kg/week. Dose adjustments based on annualized height velocity (AHV) and insulin-like growth factor I (IGF-I) response, were made up to a maximum of 0.4 mg/kg/week until achieved NAH or the patient's voluntary discontinuation.

Conditions

• Short Stature Children Born Small for Gestational Age (SGA)

Interventions

BIOLOGICAL

PEG-somatropin

Sponsors & Collaborators

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Tongji Hospital

  collaborator OTHER

• Affiliated Hospital of Jiangnan University

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• Changchun GeneScience Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Xiaoping Luo, Ph.D · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-23

Primary Completion

2023-12-12

Completion

2025-12-31

Countries

• China

Study Locations