A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
NCT ID: NCT03255694
Last Updated: 2025-08-15
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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ACTIVE_NOT_RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2017-05-12
2030-06-30
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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PEG-somatropin
After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for the high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
PEG-somatropin
After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
Interventions
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PEG-somatropin
After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Before the extension period study, the investigator shall fully inform the subjects and their guardians of all the information about the extension period study, including detailed follow-up procedure, treatment plan, laboratory examination items during follow-ups and possible benefits and risks. The extension period study shall only be initiated after the subjects and their guardians are well informed, and agree to cooperate and complete the treatment, follow-ups and examinations during the study, and sign the written informed consent.
Exclusion Criteria
1. Aromatase inhibitors (which include but are not limited to Lelrozol and Anastrozole), with continuous medication ≥1 month;
2. Gonadotropin releasing hormone analogues (which include but are not limited to Triptorelin, Leuprorelin and Goserelin),, with continuous medication ≥1 month;
3. Sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication ≥1 month;
4. Protein anabolic drugs (which include but are not limited to Oxandrolone, Danazol and Strombafort), with continuous medication ≥1 month;
5. Glucocorticoids via oral/intravenous administration for more than 1 month..
4 Years
9 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
The First Hospital of Jilin University
OTHER
Affiliated Hospital of Jiangnan University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shanghai Children's Hospital
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Children's Hospital of Fudan University
OTHER
Jiangxi Province Children's Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Beijing Children's Hospital
OTHER
Children's Hospital of Soochow University
OTHER
Wuxi Women's & Children's Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Luo
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Locations
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Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing, Beijing Municipality, China
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Soochow University
Naning, Jiangsu, China
The First Affiated Hospital of Nanjing Medical Universit
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Wuxi Children's Hospital
Wuxi, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Shanghai Children's Hospital of Fudan University
Shanghai, , China
Shanghai Children's Hospital
Shanghai, , China
Countries
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Other Identifiers
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GenSci 033 CT-Extension Period
Identifier Type: -
Identifier Source: org_study_id
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