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

Primary Purpose

Growth Hormone Deficiency

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pegylated Somatropin
pegylated Somatropin
Jintropin AQ
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency focused on measuring pegylated Somatropin, PEG-GH, Growth hormone, PEG-rhGH, Growth hormone deficiency (GHD), Phase 2 study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Growth velocity

    Secondary Outcome Measures

    height standard deviation score for chronological age (Ht SDSCA)
    IGF-1
    IGFBP3

    Full Information

    First Posted
    April 21, 2011
    Last Updated
    July 27, 2017
    Sponsor
    Changchun GeneScience Pharmaceutical Co., Ltd.
    Collaborators
    Huazhong University of Science and Technology, First Affiliated Hospital, Sun Yat-Sen University, Capital Medical University, Children's Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01342146
    Brief Title
    Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
    Acronym
    PD
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Changchun GeneScience Pharmaceutical Co., Ltd.
    Collaborators
    Huazhong University of Science and Technology, First Affiliated Hospital, Sun Yat-Sen University, Capital Medical University, Children's Hospital of Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Growth Hormone Deficiency
    Keywords
    pegylated Somatropin, PEG-GH, Growth hormone, PEG-rhGH, Growth hormone deficiency (GHD), Phase 2 study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    pegylated Somatropin
    Other Intervention Name(s)
    PEG-rhGH,PEG-growth hormone,PEG-Somatropin
    Intervention Description
    0.1 mg/kg/wk once a week for 25 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    pegylated Somatropin
    Other Intervention Name(s)
    PEG-rhGH,PEG-growth hormone,PEG-Somatropin
    Intervention Description
    0.2 mg/kg/wk once a week for 25 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Jintropin AQ
    Other Intervention Name(s)
    Somatropin injectable solution,rhGH injection
    Intervention Description
    0.25 mg/kg/wk, once a day for 25 weeks
    Primary Outcome Measure Information:
    Title
    Growth velocity
    Time Frame
    25 weeks
    Secondary Outcome Measure Information:
    Title
    height standard deviation score for chronological age (Ht SDSCA)
    Time Frame
    25 weeks
    Title
    IGF-1
    Time Frame
    25 weeks
    Title
    IGFBP3
    Time Frame
    25 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaoping Luo, Doctor
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28566441
    Citation
    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.
    Results Reference
    result

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

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