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

July 27, 2017 updated by: GeneScience Pharmaceuticals Co., Ltd.

Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Growth Hormone Deficiency

Intervention / Treatment

Biological: PEG-somatropin

Study Type

Interventional

Enrollment (Actual)

343

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China
  - Changchun, China
  - Guangzhou, China
  - Hangzhou, China
  - Shanghai, China
  - Wu Han, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
yearly growth velocity Time Frame: 6 months	growth velocity add as GV was the primary outcome measure	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSca Time Frame: 6 months	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	6 months
IGF-l Time Frame: 6 months		6 months
IGFBP-3 Time Frame: 6 months		6 months
bone maturity Time Frame: 6 months		6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeneScience Pharmaceuticals Co., Ltd.

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Tongji Hospital

Children's Hospital of Fudan University

The First Hospital of Jilin University

Capital Medical University

Investigators

Principal Investigator: Xiaoping Luo, Ph. D, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria