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Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

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, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

    • According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
    • Height velocity (HV) ≤5.0 cm/yr.
    • GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
    • Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
  • Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
  • Receive no prior GH treatment within 6 months.
  • Sign informed consent.

Exclusion Criteria:

  • People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
  • Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
  • People with known highly allergic constitution or allergy to the drug of the study.
  • People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
  • Diabetic.
  • Potential tumor patients (family history).
  • Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
  • Subjects took part in other clinical trial study within 3 months.
  • Other conditions which in the opinion of the investigator preclude enrollment into the study.

Sites / Locations

  • Children's Hospital Affiliated to Capital Institute of PediatricsRecruiting
  • Chinese Academy of Medical Sciences &Peking Union Medical CollegeRecruiting
  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • Affiliated Hospital, Jiangnan UniversityRecruiting
  • First Hospital of Jilin UniversityRecruiting
  • Shandong Provincial HospitalRecruiting
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • Children's Hospital of Fudan UniversityRecruiting
  • Children's Hospital of ShanghaiRecruiting
  • West China Second University HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang UniversityRecruiting
  • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PEG-somatropin

PEG-Somatropin

Arm Description

0.12mg/kg/w

0.20mg/kg/w

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

Full Information

First Posted
March 2, 2015
Last Updated
June 14, 2017
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02380235
Brief Title
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of 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
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-somatropin
Arm Type
Experimental
Arm Description
0.12mg/kg/w
Arm Title
PEG-Somatropin
Arm Type
Experimental
Arm Description
0.20mg/kg/w
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
0.20mg/kg/w
Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Intervention Description
0.12mg/kg/w
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

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, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD. According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender. Height velocity (HV) ≤5.0 cm/yr. GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml. Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA). Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years. Receive no prior GH treatment within 6 months. Sign informed consent. Exclusion Criteria: People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value). Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg). People with known highly allergic constitution or allergy to the drug of the study. People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency. Diabetic. Potential tumor patients (family history). Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome. Subjects took part in other clinical trial study within 3 months. Other conditions which in the opinion of 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
Facility Information:
Facility Name
Children's Hospital Affiliated to Capital Institute of Pediatrics
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese Academy of Medical Sciences &Peking Union Medical College
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital, Jiangnan University
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
West China Second University Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

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