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A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03189160
Recruitment Status : Unknown
Verified June 2017 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 16, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Beijing Children's Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of Jilin University
Jiangxi Province Children's Hospital
Affiliated Hospital of Jiangnan University
The Children's Hospital of Zhejiang University School of Medicine
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Turner Syndrome Biological: PEG-rhGH low dose Biological: PEG-rhGH high dose Other: Non-treatment control group Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Pegylated Recombinant Human Growth Hormone Injection to Treat Children of Turner Syndrome
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018


Arm Intervention/treatment
Experimental: PEG-rhGH low dose
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
Biological: PEG-rhGH low dose
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
Other Name: Polyethylene Glycol Recombinant Human Somatropin Injection

Biological: PEG-rhGH high dose
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Other Name: Polyethylene Glycol Recombinant Human Somatropin Injection

Other: Non-treatment control group
Experimental: PEG-rhGH high dose
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Biological: PEG-rhGH low dose
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
Other Name: Polyethylene Glycol Recombinant Human Somatropin Injection

Biological: PEG-rhGH high dose
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Other Name: Polyethylene Glycol Recombinant Human Somatropin Injection

Other: Non-treatment control group
No Intervention: Non-treatment control group



Primary Outcome Measures :
  1. Change of height standard deviation score before and after treatment (ΔHT SDS) [ Time Frame: 52 weeks ]
    The change of height standard deviation score of chronological age before and after treatment


Secondary Outcome Measures :
  1. Height Velocity [ Time Frame: 52 weeks ]
    Annual growth rate at the end of treatment

  2. ΔBA/ΔCA [ Time Frame: 52 weeks ]
    Bone maturation (changes of bone age/ chang of chronological age)

  3. IGF-1(Insulin-like growth factor 1) SDS [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189160


Contacts
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Contact: Xiaohua Feng 0431-85170552 fengxiaohua@gensci-china.com

Locations
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China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Yuhua Hu         
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China
Contact: Zhuangjian Xu         
China, Jiangxi
Jiangxi Provincial Children's Hospital Recruiting
Nanchang, Jiangxi, China
Contact: Yu Yang         
China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: Hongwei Du         
China, Zhejiang
The Children's Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Junfeng Fu         
China
Beijing Children's Hospital,Capital Medical University Recruiting
Beijing, China
Contact: Chunxiu Gong, PhD         
Children's Hospital of Fudan University Recruiting
Shanghai, China
Contact: Feihong Luo         
Shanghai Children's Hospital Recruiting
Shanghai, China
Contact: Pin Li         
Xinhua Hospital of Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China
Contact: Jun Ye         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Beijing Children's Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of Jilin University
Jiangxi Province Children's Hospital
Affiliated Hospital of Jiangnan University
The Children's Hospital of Zhejiang University School of Medicine
Investigators
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Principal Investigator: Chunxiu Gong, PhD Beijing Children's Hospital

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03189160     History of Changes
Other Study ID Numbers: GenSci 032 CT
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
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Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female