Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)

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

Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years 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:

  • patients with severe cardiopulmonary
  • patients with hematological diseases
  • a current or past history of malignant tumors
  • immunodeficiency diseases
  • mental diseases
  • patients positive for hepatitis B e-antibody (HBeAb)
  • hepatitis B surface antigen (HBsAg)
  • hepatitis B e antigen (HBeAg)
  • patients with other growth disorders, such as Turner syndrome
  • constitutional delay of growth and puberty, and Laron syndrome

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth velocity
Time Frame: 25 weeks
25 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
height standard deviation score for chronological age (Ht SDSCA)
Time Frame: 25 weeks
25 weeks
IGF-1
Time Frame: 25 weeks
25 weeks
IGFBP3
Time Frame: 25 weeks
25 weeks

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
Huazhong University of Science and Technology
Children's Hospital of Fudan University
Capital Medical University

Investigators

  • Principal Investigator: Xiaoping Luo, Doctor, 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

Helpful Links

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

May 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 25, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSci-004 CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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