A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
NCT ID: NCT05353192
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
38 participants
INTERVENTIONAL
2022-09-23
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recombinant human growth hormone
Recombinant human growth hormone Injection (15IU/5mg/3ml/bottle)；0.05 mg/kg/d by subcutaneous injection for 52 weeks
Recombinant human growth hormone
Recombinant human growth hormone (15IU/5mg/3ml/bottle)，0.05 mg/kg/d by subcutaneous injection for 52 weeks
Interventions
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Recombinant human growth hormone
Recombinant human growth hormone (15IU/5mg/3ml/bottle)，0.05 mg/kg/d by subcutaneous injection for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* In Tanner I stage;
* ACH, documented and confirmed by genetic testing;
* Short stature;
* Ambulatory and able to stand or walk without assistance;
* Parent(s) or guardian(s) consent；
* Had never been treated with growth hormone
Exclusion Criteria
* Evidence of growth plate closure (proximal tibia, distal femur);
* Had a fracture of the long bones within 6 months prior to screening;
* Planned or expected bone-related surgery;
* Chronic diseases condition that affect bone metabolism and weight;
* Severe intracranial hypertension
2 Years
10 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Tongji Hospital
OTHER
Children's Hospital of Nanjing Medical University
OTHER
Jiangxi Province Children's Hospital
OTHER
Chengdu Women's and Children's Central Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Shengjing Hospital
OTHER
Shanghai Children's Hospital
OTHER
Children's Hospital of The Capital Institute of Pediatrics
OTHER
West China Second University Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Feihong Luo
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Xiaoping Luo
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Wei Gu
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Nanjing Medical University
Yu Yang
Role: PRINCIPAL_INVESTIGATOR
Jiangxi Province Children's Hospital
Xinran Cheng
Role: PRINCIPAL_INVESTIGATOR
Chengdu Women's and Children's Central Hospital
Guimei Li
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Ying Xin
Role: PRINCIPAL_INVESTIGATOR
Shengjing Hospital of China Medical Hospital
Pin Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Hospital
Xiaobo Chen
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of The Capital Institute of Pediatrics
Jin Wu
Role: PRINCIPAL_INVESTIGATOR
West China Second University Hospital
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenSci001-01
Identifier Type: -
Identifier Source: org_study_id
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