Back to resultsPegylated Somatropin (PEG Somatropin) in the Treatment of Children With 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
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency
Eligibility Criteria
Inclusion Criteria:
Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
- According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
- Height velocity (HV) ≤5.0 cm / yr;
- GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
- bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
- Before puberty (Tanner I stage), age≥3 years old, male or female;
- Subjects have not received hormone therapy within 6 months;
- Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria:
- Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
- Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
- Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product;
- Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;
- Potential cancer patients (family history);
- Patients with diabetics;
- Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
- Patients with congenital bone dysplasia or scoliosis;
- Subjects took part in other clinical trial study during 3 months;
- Other conditions in which the investigator preclude enrollment into the study.
Sites / Locations
- Maternal and Child Health Hospital of Anhui provinceRecruiting
- First People's Hospital of Lu'an CityRecruiting
- Second Hospital of Lanzhou UniversityRecruiting
- Maternal and Child Health Hospital of Guiyang CityRecruiting
- Maternal and Child Health Hospital of Hainan provinceRecruiting
- Hebei Provincial People's HospitalRecruiting
- First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
- Maternal and Child Health Hospital of Hubei provinceRecruiting
- First People's Hospital of Changzhou CityRecruiting
- First People's Hospital of Lianyungang CityRecruiting
- Jiangsu Provincial Hospital of Chinese Traditional medicineRecruiting
- Affiliated Hospital of Nantong UniversityRecruiting
- Suzhou City HospitalRecruiting
- Second Affiliated Hospital of Nanchang UniversityRecruiting
- Maternal and Child Health Hospital of Tai'an cityRecruiting
- Children's Hospital of Chengdu cityRecruiting
- People's Hospital of Cixi CityRecruiting
- First People's HospitalRecruiting
- First People's Hospital of Jiaxing CityRecruiting
- Jinhua Central HospitalRecruiting
- Jishuitan Hospital of Beijing CityRecruiting
- Peoples' hospital of Inner Mongolia Autonomous RegionRecruiting
- General Hospital of Ningxia Medical UniversityRecruiting
- Children's Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
PEG-somatropin
PEG-somatropin per two weeks
Jintropin AQ
Arm Description
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
Outcomes
Primary Outcome Measures
Ht SDSca
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
Secondary Outcome Measures
Ht SDSBA
Calculate by formula
Yearly growth velocity
Calculate by formula
IGF-1SDS
Calculate by formula
IGF-1/IGFBP-3 molar ratio
Calculate by formula
Bone age
Calculate by formula
Full Information
NCT ID
NCT02976675
First Posted
November 24, 2016
Last Updated
June 14, 2017
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Children's Hospital of Fudan University, Suzhou Municipal Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Henan University of Science and Technology, Maternal and Child Health Hospital of Hubei Province, Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT02976675
Brief Title
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
Official Title
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (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
Children's Hospital of Fudan University, Suzhou Municipal Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Henan University of Science and Technology, Maternal and Child Health Hospital of Hubei Province, Nantong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
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
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG-somatropin
Arm Type
Experimental
Arm Description
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Arm Title
PEG-somatropin per two weeks
Arm Type
Experimental
Arm Description
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
Arm Title
Jintropin AQ
Arm Type
Active Comparator
Arm Description
Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
Primary Outcome Measure Information:
Title
Ht SDSca
Description
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
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
Secondary Outcome Measure Information:
Title
Ht SDSBA
Description
Calculate by formula
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
Title
Yearly growth velocity
Description
Calculate by formula
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
Title
IGF-1SDS
Description
Calculate by formula
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
Title
IGF-1/IGFBP-3 molar ratio
Description
Calculate by formula
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
Title
Bone age
Description
Calculate by formula
Time Frame
Baseline, 4,12,26 weeks after initiating treatment
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:
Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
Height velocity (HV) ≤5.0 cm / yr;
GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
Before puberty (Tanner I stage), age≥3 years old, male or female;
Subjects have not received hormone therapy within 6 months;
Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria:
Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product;
Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;
Potential cancer patients (family history);
Patients with diabetics;
Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
Patients with congenital bone dysplasia or scoliosis;
Subjects took part in other clinical trial study during 3 months;
Other conditions in which the investigator preclude 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
Feihong Luo, Doctor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Anhui province
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital of Lu'an City
City
Lu'an
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Second Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Name
Maternal and Child Health Hospital of Guiyang City
City
Guiyangtou
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
Maternal and Child Health Hospital of Hainan province
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Name
Hebei Provincial People's Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Maternal and Child Health Hospital of Hubei province
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital of Changzhou City
City
Changzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital of Lianyungang City
City
Lianyungang
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Provincial Hospital of Chinese Traditional medicine
City
Nanjingkou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Suzhou City Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Maternal and Child Health Hospital of Tai'an city
City
Tai'an
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Chengdu city
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Cixi City
City
Cixi
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
First People's Hospital of Jiaxing City
City
Jiaxing
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Jinhua Central Hospital
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Jishuitan Hospital of Beijing City
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peoples' hospital of Inner Mongolia Autonomous Region
City
Inner Mongolia Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Ningxia Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feihong Luo, Doctor
Phone
18017590900
Email
luo_fh@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34899612
Citation
Sun C, Lu B, Liu Y, Zhang Y, Wei H, Hu X, Hu P, Zhao Q, Liu Y, Ye K, Wang K, Gu Z, Liu Z, Ye J, Zhang H, Zhu H, Jiang Z, Liu Y, Wan N, Yan C, Yin J, Ying L, Huang F, Yin Q, Xi L, Luo F, Cheng R. Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. Front Endocrinol (Lausanne). 2021 Nov 25;12:779365. doi: 10.3389/fendo.2021.779365. eCollection 2021. Erratum In: Front Endocrinol (Lausanne). 2021 Dec 28;12:830469.
Results Reference
derived
Learn more about this trial
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
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