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Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

NCT01342146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2017-07-31

No results posted yet for this study

Summary

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

pegylated Somatropin

0.1 mg/kg/wk once a week for 25 weeks

DRUG

pegylated Somatropin

0.2 mg/kg/wk once a week for 25 weeks

DRUG

Jintropin AQ

0.25 mg/kg/wk, once a day for 25 weeks

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Capital Medical University

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo, Doctor · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-01-31
Completion
2007-02-28

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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 NCT01342146 on ClinicalTrials.gov