Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
NCT ID: NCT03635580
Last Updated: 2018-08-17
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
PHASE3
480 participants
INTERVENTIONAL
2018-06-11
2021-10-30
Brief Summary
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Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rhGH/Jintropin AQ
Jintropin AQ, injection, 30IU/10mg/3ml/cartridge, 0.05mg /kg/d in phase 1 and 0.05-0.07mg/kg/d in phase 2.
Negative control
Untreated-control group
Interventions
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Negative control
Untreated-control group
Eligibility Criteria
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Inclusion Criteria
* Height \<-2.25 SD (Standard deviation) for chronological age;
* GH (Growth hormone) peak concentration ≥10.0 ng/mL in GH stimulation tests;
* The bone age (BA) ≤chronological age (CA)+6 months;
* Prepubertal Status (Tanner Stage I);
* Birth weight within the normal range;
* Growth hormone treatment-naive;
* Participants are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria
* Participants are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
* Participants with known highly allergic constitution or allergy to investigational product or its excipient;
* Participants with systemic chronic disease and immune deficiency;
* Participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment;
* Participants with mental disease;
* Participants with other types of abnormal growth and development;
1. Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
2. Turner syndrome (confirmed by karyotype test of girls);
3. Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the participants, for both male and female participants);
4. Laron syndrome (confirmed by IGF-1 generation test);
5. Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old);
6. Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
* Participants with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes;
* BMI (Body mass index) ≥22kg/m²;
* Congenital skeletal abnormalities or scoliosis, claudication;
* Participants who took part in other clinical trials within 3 months;
* Participants who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.);
* Other conditions which is inappropriate for this study in the opinion of the investigator.
4 Years
10 Years
ALL
No
Sponsors
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The Children's Hospital of Zhejiang University School of Medicine
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Henan Provincial People's Hospital
OTHER
Children's Hospital of Fudan University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shanxi Provincial Maternity and Children's Hospital
OTHER
The First Hospital of Jilin University
OTHER
Shanghai Children's Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Junfen Fu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Children's Hospital of Zhejiang University School of Medicine
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Children's Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Children's Hospital of Shanxi
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Children's Hospital of Fudan University
Shanghai, , China
Children's Hospital of Shanghai
Shanghai, , China
Countries
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Central Contacts
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References
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Yuan J, Fu J, Wei H, Zhang G, Xiao Y, Du H, Gu W, Li Y, Chen L, Luo F, Zhong Y, Gong H. A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short Stature. Front Endocrinol (Lausanne). 2022 Apr 29;13:864908. doi: 10.3389/fendo.2022.864908. eCollection 2022.
Other Identifiers
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GenSci 046 CT
Identifier Type: -
Identifier Source: org_study_id
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