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Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

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: NCT02908958
Recruitment Status : Unknown
Verified September 2016 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : September 21, 2016
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
The Children's Hospital of Zhejiang University School of Medicine
The Second Hospital of Anhui Medical University
Guangzhou Women and Children's Medical Center
First People's Hospital of Hangzhou
Qilu Hospital of Shandong University
Zhejiang Provincial People’s Hospital
Zhejiang Provincial Hospital of TCM
Central South University
Southwest Hospital, China
First Affiliated Hospital of Guangxi Medical University
Shanghai Children's Medical Center
Second Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Xiamen University
Third Affiliated Hospital, Sun Yat-Sen University
Xiangya Hospital of Central South University
Shaoxing Second Hospital
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief Summary:
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to 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 : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II
Study Start Date : November 2014
Estimated Primary Completion Date : June 2017


Arm Intervention/treatment
Experimental: PEG-somatropin
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Biological: PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Experimental: PEG-Somatropin
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

Biological: PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.




Primary Outcome Measures :
  1. The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) [ Time Frame: 26 weeks ]
    HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age


Secondary Outcome Measures :
  1. HtSDSBA [ Time Frame: 26 weeks ]
    HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender

  2. Annual height velocity [ Time Frame: 26 weeks ]
    Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)

  3. Standard Deviation Score of serum IGF-1 (IGF-1 SDS) [ Time Frame: 26 weeks ]
    IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age

  4. Bone Maturation [ Time Frame: 26 weeks ]
    Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)



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, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
  • According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
  • Height velocity (HV) ≤5.0 cm/yr.
  • GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
  • Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
  • Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
  • The child did not receive the treatment of growth hormone within 6 months.
  • Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Exclusion Criteria:

  • The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
  • The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
  • The child is known as hypersensitivity to PEG Somatropin.
  • The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
  • The child has potential tumor (family history).
  • The child has diabetics.
  • The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
  • The child took part in other clinical trials within 3 months.
  • Other conditions are excluded when the investigator preclude the 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): NCT02908958


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

Locations
Show Show 22 study locations
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
The Children's Hospital of Zhejiang University School of Medicine
The Second Hospital of Anhui Medical University
Guangzhou Women and Children's Medical Center
First People's Hospital of Hangzhou
Qilu Hospital of Shandong University
Zhejiang Provincial People’s Hospital
Zhejiang Provincial Hospital of TCM
Central South University
Southwest Hospital, China
First Affiliated Hospital of Guangxi Medical University
Shanghai Children's Medical Center
Second Affiliated Hospital of Wenzhou Medical University
The First Affiliated Hospital of Xiamen University
Third Affiliated Hospital, Sun Yat-Sen University
Xiangya Hospital of Central South University
Shaoxing Second Hospital
Investigators
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Principal Investigator: Junfen Fu, PhD The Children's Hospital of Zhejiang University School of Medicine

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02908958    
Other Study ID Numbers: GenSci 004 CT-Zhejiang
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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
Physiological Effects of Drugs