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Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Primary Purpose

Growth Hormone Deficiency

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-somatropin
PEG-somatropin
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Wuhu No.1 People's HospitalRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Guangzhou Women and Children's Medical CenterRecruiting
  • The Third Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Harbin Children's HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital, Central South UniversityRecruiting
  • Children's Hospital of ChangchunRecruiting
  • Qilu Children's Hospital of Shandong UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Chengdu Women and Children's Central HospitalRecruiting
  • Hangzhou First People's HospitalRecruiting
  • The Children's Hospital ,Zhejiang University School of MedicineRecruiting
  • Zhejiang Provincial Hospital of Traditional Chinese Medcine HospitalRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Ningbo Women and Children's HospitalRecruiting
  • Shaoxing Second HospitalRecruiting
  • The Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Southwest Hospital, Third Military Medical UniversityRecruiting
  • Shanghai Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEG-somatropin

PEG-Somatropin

Arm Description

Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.

High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.

Outcomes

Primary Outcome Measures

The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
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

HtSDSBA
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
Annual height velocity
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
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
Bone Maturation
Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)

Full Information

First Posted
September 19, 2016
Last Updated
June 13, 2017
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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
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1. Study Identification

Unique Protocol Identification Number
NCT02908958
Brief Title
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-somatropin
Arm Type
Experimental
Arm Description
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Arm Title
PEG-Somatropin
Arm Type
Experimental
Arm Description
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Primary Outcome Measure Information:
Title
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
Description
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
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
HtSDSBA
Description
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
Time Frame
26 weeks
Title
Annual height velocity
Description
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
Time Frame
26 weeks
Title
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
Description
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
Time Frame
26 weeks
Title
Bone Maturation
Description
Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohua Feng
Phone
13610794989
Email
fengxiaohua@gensci-china.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junfen Fu, PhD
Organizational Affiliation
The Children's Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deyun Liu, MD
Facility Name
Wuhu No.1 People's Hospital
City
Wuhu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayan Pan, MD
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Lian, MD
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Liu, MD
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunye Zhu, MD
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Lan, MD
Facility Name
Harbin Children's Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Yu, MD
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxing Zhang, MD
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhi Cao, MD
Facility Name
Children's Hospital of Changchun
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Liu, MD
Facility Name
Qilu Children's Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongmei Zhao, MD
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhua Dong, MD
Facility Name
Chengdu Women and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinran Cheng, MD
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingjuan Dai, MD
Facility Name
The Children's Hospital ,Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfen Fu, PhD
Facility Name
Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Dong
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Luo, MD
Facility Name
Ningbo Women and Children's Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Zhang, MD
Facility Name
Shaoxing Second Hospital
City
Shaoxing
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manyan Zhang, MD
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjiang Jin, MD
Facility Name
Southwest Hospital, Third Military Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liao, MD
Facility Name
Shanghai Children's Medical Center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Huang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
36034802
Citation
Jiang Z, Chen X, Dong G, Lou Y, Zhang J, Cheng X, Pan J, Liao W, Wu J, Huang X, Jin X, Liu D, Zeng T, Zhu S, Dong Q, Luo X, Lan D, Cao L, Zhang X, Liu J, Dai M, Zhang M, Liu L, Dong J, Zhao D, Ni S, Fu J. Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study. Front Pharmacol. 2022 Aug 11;13:955809. doi: 10.3389/fphar.2022.955809. eCollection 2022.
Results Reference
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Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

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