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

This study has been completed.

Sponsor:

Collaborators:

Huazhong University of Science and Technology

First Affiliated Hospital, Sun Yat-Sen University

Capital Medical University

Children's Hospital of Fudan University

Information provided by:

GeneScience Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01342146

First received: April 21, 2011

Last updated: May 9, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 21, 2011

Last Updated Date

May 9, 2011

Start Date ^ICMJE

May 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Growth velocity [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Growth velocity [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01342146 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

height standard deviation score for chronological age (Ht SDSCA) [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
IGF-1 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
IGFBP3 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

height standard deviation score for chronological age (Ht SDSCA)and IGF-1 and IGFBP3 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Growth Hormone Deficiency

Intervention ^ICMJE

Drug: pegylated Somatropin
0.1 mg/kg/wk once a week for 25 weeks

Other Name: PEG-rhGH,PEG-growth hormone,PEG-Somatropin
Drug: pegylated Somatropin
0.2 mg/kg/wk once a week for 25 weeks

Other Name: PEG-rhGH,PEG-growth hormone,PEG-Somatropin
Drug: Jintropin AQ
0.25 mg/kg/wk, once a day for 25 weeks

Other Name: Somatropin injectable solution,rhGH injection

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

101

Completion Date

February 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01342146

Other Study ID Numbers ^ICMJE

GenSci-004 CT

Has Data Monitoring Committee

Yes

Responsible Party

International Regulatory Affairs Department, GeneScience Pharmaceuticals Co., Ltd.

Study Sponsor ^ICMJE

GeneScience Pharmaceuticals Co., Ltd.

Collaborators ^ICMJE

Huazhong University of Science and Technology
First Affiliated Hospital, Sun Yat-Sen University
Capital Medical University
Children's Hospital of Fudan University

Investigators ^ICMJE

Principal Investigator:

Xiaoping Luo, Doctor

Huazhong University of Science and Technology

Information Provided By

GeneScience Pharmaceuticals Co., Ltd.

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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