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

December 9, 2014 updated by: GeneScience Pharmaceuticals Co., Ltd.
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 population of children. Half of participants will receive the high dose, while the other half will receive the low dose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

  • Name: Junfen Fu, Ph.D
  • Phone Number: 13777457849
  • Email: fjf68@qq.com

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China
        • Recruiting
        • First People's Hospital of Wuhu
        • Contact:
          • Jiayan Pan
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Children's Hospital Affiliated to Zhejiang University
        • Contact:
          • Junfen Fu, Ph.D
          • Phone Number: 13777457849
          • Email: fjf68@qq.com

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

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 B e 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.
  • Potential tumor patients (family history).
  • Diabetic.
  • 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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-somatropin
Biological: PEG-somatropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Actual height of the patient after treatment compared with the mean height of the population and the standard deviation (SD) of the height of the population for that chronological age
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

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

Sponsor

GeneScience Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Junfen Fu, Ph.D, Children's Hospital Affiliated to Medical College of Zhejiang University

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

November 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (ESTIMATE)

December 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

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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