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Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

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ClinicalTrials.gov Identifier: NCT02380235
Recruitment Status : Unknown
Verified June 2017 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 5, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief Summary:
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Biological: PEG-somatropin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: PEG-somatropin
0.12mg/kg/w
Biological: PEG-somatropin
0.20mg/kg/w

Biological: PEG-somatropin
0.12mg/kg/w

Experimental: PEG-Somatropin
0.20mg/kg/w
Biological: PEG-somatropin
0.20mg/kg/w

Biological: PEG-somatropin
0.12mg/kg/w




Primary Outcome Measures :
  1. Ht SDSca [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

    • According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
    • Height velocity (HV) ≤5.0 cm/yr.
    • GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
    • Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
  • Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
  • Receive no prior GH treatment within 6 months.
  • Sign informed consent.

Exclusion Criteria:

  • People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
  • Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
  • People with known highly allergic constitution or allergy to the drug of the study.
  • People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
  • Diabetic.
  • Potential tumor patients (family history).
  • Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
  • Subjects took part in other clinical trial study within 3 months.
  • Other conditions which in the opinion of the investigator preclude enrollment into the study.

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): NCT02380235


Contacts
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Contact: Xiaohua Feng 13610794989 fengxiaohua@gensci-china.com

Locations
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China, Beijing
Children's Hospital Affiliated to Capital Institute of Pediatrics Recruiting
Beijing, Beijing, China
Chinese Academy of Medical Sciences &Peking Union Medical College Recruiting
Beijing, Beijing, China
China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Affiliated Hospital, Jiangnan University Recruiting
Wuxi, Jiangsu, China
China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Recruiting
Qingdao, Shandong, China
China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China
Children's Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
China, Sichuan
West China Second University Hospital Recruiting
Chengdu, Sichuan, China
China, Zhejiang
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China
China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02380235     History of Changes
Other Study ID Numbers: GenSci 004 CT-2
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases