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A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome

NCT03189160 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-12-12

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 of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.

Conditions

  • Turner Syndrome

Interventions

BIOLOGICAL

PEG-rhGH low dose

PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.

BIOLOGICAL

PEG-rhGH high dose

PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.

OTHER

Non-treatment control group

Sponsors & Collaborators

  • Beijing Children's Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Shanghai 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

  • Jiangxi Province Children's Hospital

    collaborator OTHER

  • Affiliated Hospital of Jiangnan University

    collaborator OTHER

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

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chunxiu Gong, PhD · Beijing Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-03-31

Countries

  • China

Study Locations

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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 NCT03189160 on ClinicalTrials.gov