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Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS

NCT03635580 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-08-17

No results posted yet for this study

Summary

Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.

Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years

Conditions

  • Dwarfism

Interventions

OTHER

Negative control

Untreated-control group

Sponsors & Collaborators

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

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Shanxi Provincial Maternity and Children's Hospital

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • Shanghai Children's Hospital

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junfen Fu, Doctor · The Children's Hospital of Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2021-10-31
Completion
2021-10-30

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 NCT03635580 on ClinicalTrials.gov