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Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

NCT02976675 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2017-06-16

No results posted yet for this study

Summary

To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.

Conditions

  • Growth Hormone Deficiency

Interventions

BIOLOGICAL

PEG-somatropin

Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks

BIOLOGICAL

PEG-somatropin

Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Suzhou Municipal Hospital

    collaborator OTHER

  • General Hospital of Ningxia Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Henan University of Science and Technology

    collaborator OTHER

  • Maternal and Child Health Hospital of Hubei Province

    collaborator OTHER

  • Nantong University

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Feihong Luo, Doctor · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-06-30

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 NCT02976675 on ClinicalTrials.gov