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A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

NCT03221933 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-12

No results posted yet for this study

Summary

To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.

Conditions

  • Small for Gestational Age Infant

Interventions

BIOLOGICAL

Somatropin Injection low dose group

0.23mg/kg /wk，inject for seven divided doses

BIOLOGICAL

Somatropin Injection high dose group

0.46mg/kg /wk，inject for seven divided dose

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • Beijing Children's Hospital

    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

  • 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
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
90 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-12-31

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 NCT03221933 on ClinicalTrials.gov