MedTrace Logo

A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature

NCT03221088 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-07-19

No results posted yet for this study

Summary

This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.

Conditions

  • Dwarfism

Interventions

DRUG

Jintrolong® low dose group

PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.

DRUG

Jintrolong® high dose group

PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.

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

  • 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221088 on ClinicalTrials.gov