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Pegylated 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
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:

  • Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:

    1. 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;
    2. Height velocity (HV) ≤5.0 cm / yr;
    3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
    4. 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;
  • 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

  • Anhui Provincial Children's HospitalRecruiting
  • Fuzhou Children s HospitalRecruiting
  • Sun Yat-Sen Memorial HospitalRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • Children's Hospital of Hebei ProvinceRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Children's Hospital of ZhengzhouRecruiting
  • Henan Provincal People's HospitalRecruiting
  • The First Affiliated Hospital of Henan University of TCMRecruiting
  • Union Hospital, Tongji Medical College, HUSTRecruiting
  • Wuhan Children's HospitalRecruiting
  • Hunan Children's HospitalRecruiting
  • Maternal & Child Health Hospital of Guangxi Zhuang Autonomous RegionRecruiting
  • Nanjing Children's HospitalRecruiting
  • Children's Hospital of Soochow UniversityRecruiting
  • Wuxi Children's HospitalRecruiting
  • Xuzhou Children's HpspitalRecruiting
  • Dalian Children's HospitalRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Xi'an Children's HospitalRecruiting
  • First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Kunming Children's HospitalRecruiting
  • Second Affiliated Hospital of Kunming Medical UniversityRecruiting
  • The First People's Hospital of Yunnan ProvinceRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Shenzhen Children's HospitalRecruiting
  • Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-somatropin

Arm Description

30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.

Outcomes

Primary Outcome Measures

Ht SDSca (Height Standard Deviation Score for Chronological Age)
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
Change of yearly growth velocity from baseline to 26 weeks
Height velocity calculate by formula
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 (Height Standard Deviation Score for Bone Age)
IGF-1 SDS (IGF-1 Standard Deviation Score)
IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)
Skeletal maturity
Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration

Full Information

First Posted
July 24, 2017
Last Updated
August 10, 2017
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Beijing Children's Hospital, Tianjin Medical University General Hospital, Peking University Third Hospital, China-Japan Friendship Hospital, Dalian Children's Hospital, Xian Children's Hospital, Wuhan Children's Hospital, Fuzhou Children s Hospital, Anhui Provincial Children's Hospital, Hunan Children's Hospital, Shenzhen Children's Hospital, Children's Hospital of Hebei Province, Second Affiliated Hospital of Xi'an Jiaotong University, Zhengzhou Children's Hospital, China, Children's Hospital of Soochow University, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Kunming Medical University, Kunming Children's Hospital, The First People's Hospital of Yunnan, Xuzhou Children's Hopspital, Henan Provincial People's Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, First Affiliated Hospital of Harbin Medical University, The Second Hospital of Hebei Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Union Hospital of Tongji Medical College of HUST, Wuxi Women's & Children's Hospital, The Second Affiliated Hospital of Kunming Medical University, Nanjing Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03249480
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, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
August 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
Beijing Children's Hospital, Tianjin Medical University General Hospital, Peking University Third Hospital, China-Japan Friendship Hospital, Dalian Children's Hospital, Xian Children's Hospital, Wuhan Children's Hospital, Fuzhou Children s Hospital, Anhui Provincial Children's Hospital, Hunan Children's Hospital, Shenzhen Children's Hospital, Children's Hospital of Hebei Province, Second Affiliated Hospital of Xi'an Jiaotong University, Zhengzhou Children's Hospital, China, Children's Hospital of Soochow University, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital of Kunming Medical University, Kunming Children's Hospital, The First People's Hospital of Yunnan, Xuzhou Children's Hopspital, Henan Provincial People's Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, First Affiliated Hospital of Harbin Medical University, The Second Hospital of Hebei Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Union Hospital of Tongji Medical College of HUST, Wuxi Women's & Children's Hospital, The Second Affiliated Hospital of Kunming Medical University, Nanjing Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-somatropin
Arm Type
Experimental
Arm Description
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Primary Outcome Measure Information:
Title
Ht SDSca (Height Standard Deviation Score for Chronological Age)
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
Title
Change of yearly growth velocity from baseline to 26 weeks
Description
Height velocity calculate by formula
Time Frame
Baseline, 26 weeks after initiating treatment
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
26 weeks after initiating treatment
Secondary Outcome Measure Information:
Title
Ht SDSBA (Height Standard Deviation Score for Bone Age)
Time Frame
Baseline,26 weeks after initiating treatment
Title
IGF-1 SDS (IGF-1 Standard Deviation Score)
Time Frame
Baseline,26 weeks after initiating treatment
Title
IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)
Time Frame
Baseline,26 weeks after initiating treatment
Title
Skeletal maturity
Description
Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration
Time Frame
Baseline,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: 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; 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
Chunxiu Gong
Organizational Affiliation
Beijing Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Children's Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Name
Fuzhou Children s Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiangzhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Hebei Province
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincal People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Henan University of TCM
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital, Tongji Medical College, HUST
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Children's Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi Children's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Xuzhou Children's Hpspital
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Dalian Children's Hospital
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'an Children's Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
Kunming Children's Hospital
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Shenzhen Children's Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35945517
Citation
Chen J, Zhong Y, Wei H, Chen S, Su Z, Liu L, Liang L, Lu P, Chen L, Chen R, Ni S, Wang X, Li L, Wang Y, Xu X, Xiao Y, Yao H, Liu G, Jin R, Cao B, Wu D, Su C, Li W, Qin M, Li X, Luo X, Gong C. Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study. BMC Endocr Disord. 2022 Aug 9;22(1):201. doi: 10.1186/s12902-022-01101-8.
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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