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Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

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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
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China, Anhui
The Second Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Deyun Liu, MD         
Wuhu No.1 People's Hospital Recruiting
Wuhu, Anhui, China
Contact: Jiayan Pan, MD         
China, Fujian
The First Affiliated Hospital of Xiamen University Recruiting
Xiamen, Fujian, China
Contact: Qun Lian, MD         
China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guangzhou, Guangdong, China
Contact: Li Liu, MD         
The Third Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Shunye Zhu, MD         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
Contact: Dan Lan, MD         
China, Heilongjiang
Harbin Children's Hospital Recruiting
Harbin, Heilongjiang, China
Contact: Hong Yu, MD         
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Xingxing Zhang, MD         
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China
Contact: Lizhi Cao, MD         
China, Jilin
Children's Hospital of Changchun Recruiting
Changchun, Jilin, China
Contact: Jing Liu, MD         
China, Shandong
Qilu Children's Hospital of Shandong University Recruiting
Jinan, Shandong, China
Contact: Dongmei Zhao, MD         
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China
Contact: Junhua Dong, MD         
China, Sichuan
Chengdu Women and Children's Central Hospital Recruiting
Chengdu, Sichuan, China
Contact: Xinran Cheng, MD         
China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Mingjuan Dai, MD         
The Children's Hospital ,Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Junfen Fu, PhD         
Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Qin Dong         
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Xiaoming Luo, MD         
Ningbo Women and Children's Hospital Recruiting
Ningbo, Zhejiang, China
Contact: Jianping Zhang, MD         
Shaoxing Second Hospital Recruiting
Shaoxing, Zhejiang, China
Contact: Manyan Zhang, MD         
The Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Contact: Xianjiang Jin, MD         
China
Southwest Hospital, Third Military Medical University Recruiting
Chongqing, China
Contact: Wei Liao, MD         
Shanghai Children's Medical Center Recruiting
Shanghai, China
Contact: Xiaodong Huang, MD         
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     History of Changes
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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Endocrine System Diseases
Dwarfism, Pituitary
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs