A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia

NCT05353192 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-02-28

No results posted yet for this study

Summary

To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia

Conditions

Interventions

DRUG

Recombinant human growth hormone

Recombinant human growth hormone (15IU/5mg/3ml/bottle),0.05 mg/kg/d by subcutaneous injection for 52 weeks

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • Children's Hospital of Nanjing Medical University

    collaborator OTHER
  • Jiangxi Province Children's Hospital

    collaborator OTHER
  • Chengdu Women's and Children's Central Hospital

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • Shengjing Hospital

    collaborator OTHER
  • Shanghai Children's Hospital

    collaborator OTHER
  • Children's Hospital of The Capital Institute of Pediatrics

    collaborator OTHER
  • West China Second University Hospital

    collaborator OTHER
  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Feihong Luo · Children's Hospital of Fudan University

  • Xiaoping Luo · Tongji Hospital

  • Wei Gu · Children's Hospital of Nanjing Medical University

  • Yu Yang · Jiangxi Province Children's Hospital

  • Xinran Cheng · Chengdu Women's and Children's Central Hospital

  • Guimei Li · Shandong Provincial Hospital

  • Ying Xin · Shengjing Hospital of China Medical Hospital

  • Pin Li · Shanghai Children's Hospital

  • Xiaobo Chen · Children's Hospital of The Capital Institute of Pediatrics

  • Jin Wu · West China Second University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • China

Study Locations

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Entities

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 NCT05353192 on ClinicalTrials.gov