A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome
A Phase 2 Study of Pegylated Recombinant Human Growth Hormone Injection to Treat Children of Turner Syndrome
1 other identifier
interventional
180
1 country
9
Brief Summary
This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedDecember 12, 2017
June 1, 2017
2 years
June 13, 2017
December 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of height standard deviation score before and after treatment (ΔHT SDS)
The change of height standard deviation score of chronological age before and after treatment
52 weeks
Secondary Outcomes (3)
Height Velocity
52 weeks
ΔBA/ΔCA
52 weeks
IGF-1(Insulin-like growth factor 1) SDS
52 weeks
Study Arms (3)
PEG-rhGH low dose
EXPERIMENTALPEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH high dose
EXPERIMENTALPEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Non-treatment control group
NO INTERVENTIONInterventions
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Eligibility Criteria
You may qualify if:
- Female
- 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)
You may not qualify if:
- Subjects with abnormal liver and kidney functions (ALT \> upper limit of normal value; Cr \> upper limit of normal value)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Beijing Children's Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Shanghai Children's Hospitalcollaborator
- Children's Hospital of Fudan Universitycollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- The First Hospital of Jilin Universitycollaborator
- Jiangxi Province Children's Hospitalcollaborator
- Affiliated Hospital of Jiangnan Universitycollaborator
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
Study Sites (9)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunxiu Gong, PhD
Beijing Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 16, 2017
Study Start
March 1, 2016
Primary Completion
March 1, 2018
Last Updated
December 12, 2017
Record last verified: 2017-06