We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01342146
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : July 31, 2017
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: pegylated Somatropin Drug: Jintropin AQ Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006
Primary Completion Date : January 2007
Study Completion Date : February 2007

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Growth velocity [ Time Frame: 25 weeks ]

Secondary Outcome Measures :
  1. height standard deviation score for chronological age (Ht SDSCA) [ Time Frame: 25 weeks ]
  2. IGF-1 [ Time Frame: 25 weeks ]
  3. IGFBP3 [ Time Frame: 25 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342146

Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Huazhong University of Science and Technology
First Affiliated Hospital, Sun Yat-Sen University
Capital Medical University
Children's Hospital of Fudan University
Principal Investigator: Xiaoping Luo, Doctor Tongji Hospital
More Information

Additional Information:
Responsible Party: International Regulatory Affairs Department, GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342146     History of Changes
Other Study ID Numbers: GenSci-004 CT
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: May 2011

Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
pegylated Somatropin
Growth hormone
Growth hormone deficiency (GHD)
Phase 2 study

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs