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Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PEG-somatropin
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency focused on measuring pegylated somatropin, PEG-rhGH, growth hormone, Growth Hormone Deficiency, phase III study

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
  • be in preadolescence (Tanner stage 1) and have a CA > 3 years
  • have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
  • receive no prior GH treatment.
  • sign informed consent

Exclusion Criteria:

  • 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
  • 2.Known hypersensitivity to Somatropin or any other components of the study product.
  • 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
  • 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
  • 5. Subjects took part in other clinical trial study during 3 months.
  • 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.

Sites / Locations

Outcomes

Primary Outcome Measures

yearly growth velocity
growth velocity add as GV was the primary outcome measure

Secondary 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
IGF-l
IGFBP-3
bone maturity

Full Information

First Posted
December 16, 2011
Last Updated
July 27, 2017
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, Capital Medical University, Children's Hospital of Fudan University, The First Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT01495468
Brief Title
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
Official Title
Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, Capital Medical University, Children's Hospital of Fudan University, The First Hospital of Jilin University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
Keywords
pegylated somatropin, PEG-rhGH, growth hormone, Growth Hormone Deficiency, phase III study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
PEG-somatropin
Other Intervention Name(s)
recombinant human growth hormone, peglyated growth hormone, PEG-GH
Intervention Description
drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months
Primary Outcome Measure Information:
Title
yearly growth velocity
Description
growth velocity add as GV was the primary outcome measure
Time Frame
6 months
Secondary 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
6 months
Title
IGF-l
Time Frame
6 months
Title
IGFBP-3
Time Frame
6 months
Title
bone maturity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA) be in preadolescence (Tanner stage 1) and have a CA > 3 years have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV. receive no prior GH treatment. sign informed consent Exclusion Criteria: 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) 2.Known hypersensitivity to Somatropin or any other components of the study product. 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome 5. Subjects took part in other clinical trial study during 3 months. 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Luo, Ph. D
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
City
Beijing
Country
China
City
Changchun
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Shanghai
Country
China
City
Wu Han
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28566441
Citation
Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.
Results Reference
result

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Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

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