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

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ClinicalTrials.gov Identifier: NCT02314676
Recruitment Status : Unknown
Verified December 2014 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
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 population of children. Half of participants will receive the high dose, while the other half will receive the low dose.

Condition or disease Intervention/treatment Phase
Dwarfism, Pituitary Biological: PEG-somatropin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : July 2017


Arm Intervention/treatment
Experimental: PEG-somatropin Biological: PEG-somatropin



Primary Outcome Measures :
  1. Actual height of the patient after treatment compared with the mean height of the population and the standard deviation (SD) of the height of the population for that chronological age [ Time Frame: 26 weeks ]


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older 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 B e 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.
  • Potential tumor patients (family history).
  • Diabetic.
  • 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): NCT02314676


Contacts
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Contact: Junfen Fu, Ph.D 13777457849 fjf68@qq.com

Locations
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China, Anhui
First People's Hospital of Wuhu Recruiting
Wuhu, Anhui, China
Contact: Jiayan Pan         
China, Zhejiang
Children's Hospital Affiliated to Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Junfen Fu, Ph.D    13777457849    fjf68@qq.com   
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Junfen Fu, Ph.D Children's Hospital Affiliated to Medical College of Zhejiang University

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02314676     History of Changes
Other Study ID Numbers: GenSci 004 CT
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Dwarfism
Dwarfism, Pituitary
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism