A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
NCT ID: NCT03189160
Last Updated: 2017-12-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG-rhGH low dose
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH low dose
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH high dose
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Non-treatment control group
PEG-rhGH high dose
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH low dose
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH high dose
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Non-treatment control group
Non-treatment control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEG-rhGH low dose
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH high dose
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Non-treatment control group
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Bone age \<12 years
* Karyotype: 45, X; 45, X / 46, XXqi; 45, X / 46, XXr; 45, X / 46, XX; 46, XXqi; 46, XXpi; 45, X / 47, XXX; 46, XXp-; 45, X / 46, XXp-; 46, XXq-; 45X / 46, XXq-; 45, X / 46, XX / 47, XXX, etc. (count 50 or more cells);
* Facial appearance and abnormalities: Patients with at least one of the following signs, which include but are not limited to facial pigmented nevus, short neck, webbed neck, low posterior hairline, low-set ears, micrognathia, high-voulted arch, shield-like chest, cubitus valgus, genu valgum, short 4th and 5th metacarpals, nail dysplasia, scoliosis, ptosis and strabismus, cardiovascular abnormalities (such as aortic stenosis, bicuspid aortic valve and hypertension), reproductive abnormalities (such as primary gonadal dysfunction), renal abnormalities, thyroid hypofunction, middle ear lesion, etc.
* Short stature: height below -2.5SD of the mean height of the same age and gender.
* Pre-pubertal (Tanner Stage I ) patients
* No history of growth hormone treatment
* The subject and his/her guardian sign the informed consent (if the subject is incapable to sign the informed consent, his/her legal guardian shall sign the name of the subject instead)
Exclusion Criteria
* Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
* Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient
* Subjects with systemic chronic disease and immune deficiency
* Patients diagnosed with tumor
* For patients whose tumor markers exceeding normal range in combination with other information, considering as potential high risks of tumor, they may be excluded from the treatment.
* Patients with mental disease
* Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes
* Subjects who took part in other clinical trials within 3 months
* Subjects who received medicines which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.)
* Other conditions which are unsuitable for this study in the opinion of the investigator.
2 Years
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Children's Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shanghai Children's Hospital
OTHER
Children's Hospital of Fudan University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
The First Hospital of Jilin University
OTHER
Jiangxi Province Children's Hospital
OTHER
Affiliated Hospital of Jiangnan University
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chunxiu Gong, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Children's Hospital,Capital Medical University
Beijing, , China
Children's Hospital of Fudan University
Shanghai, , China
Shanghai Children's Hospital
Shanghai, , China
Xinhua Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yuhua Hu
Role: primary
Zhuangjian Xu
Role: primary
Yu Yang
Role: primary
Hongwei Du
Role: primary
Junfeng Fu
Role: primary
Chunxiu Gong, PhD
Role: primary
Feihong Luo
Role: primary
Pin Li
Role: primary
Jun Ye
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GenSci 032 CT
Identifier Type: -
Identifier Source: org_study_id