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A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature

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: NCT03221088
Recruitment Status : Unknown
Verified July 2017 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 18, 2017
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Tongji Hospital
First Hospital of Jilin University
Affiliated Hospital of Jiangnan University
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Children's Hospital of Fudan University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE July 18, 2017
Last Update Posted Date July 19, 2017
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) [ Time Frame: Baseline,52 weeks ]
Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) from Baseline to 52 weeks;ΔHtSDSCA=(height Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the height value at particular timepoint x)
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
ΔHtSDSCA [ Time Frame: Baseline,52 weeks ]
Change in Height Standard Deviation Score for Chronological Age (ΔHtSDSCA) from Baseline to 52 weeks;ΔHtSDSCA=(height Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the height value at particular timepoint x)
Change History Complete list of historical versions of study NCT03221088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Change in Annualized Height Velocity [ Time Frame: Baseline,52 weeks ]
    Annualized Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the height value at particular timepoint x)
  • Change in Bone Maturation [ Time Frame: Baseline,52 weeks ]
    Bone Maturation=(BA Yx-BA at Baseline)/(Date of Yx - Date of Baseline) (Yx refers to the BA value at particular timepoint x)
  • Change in IGF-1 Standard Deviation Score (IGF-1 SDS) [ Time Frame: Baseline,52 weeks ]
    GF-1 SDS=(IGF-1 Yx - reference mean for CA Yx) / reference SD for CA Yx (Yx refers to the IGF-1 value at particular timepoint x)
  • IGF-1/IGFBP-3 molar ratio at 52 weeks [ Time Frame: Baseline,52 weeks ]
    IGF-1/IGFBP-3 molar ration=[IGF-1(ng/ml)/7.6]/[IGFBP-3 (ng/ml)/25.75]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature
Official Title  ICMJE Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Idiopathic Short Stature: A Controlled, Prospective, Randomized, Multicenter Phase-II Study With An Untreated Control Group.
Brief Summary This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and reliable evidence for the medication dosage in Phase III clinical study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dwarfism
Intervention  ICMJE
  • Drug: Jintrolong® low dose group
    PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
    Other Name: PEG-somatropin
  • Drug: Jintrolong® high dose group
    PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
    Other Name: PEG-somatropin
Study Arms  ICMJE
  • Experimental: Jintrolong® low dose group
    PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
    Interventions:
    • Drug: Jintrolong® low dose group
    • Drug: Jintrolong® high dose group
  • Experimental: Jintrolong® high dose group
    PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
    Interventions:
    • Drug: Jintrolong® low dose group
    • Drug: Jintrolong® high dose group
  • No Intervention: Negative control group
    Untreated Control Group
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2017)
360
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Boys are between 4 and 9 years of age and girls are between 4 and 8 years of age.
  • Height <-2 SD for chronological age.
  • Growth velocity<5.0 cm/yr.
  • GH peak concentration ≥10.0 ng/mL in two different stimulation tests.
  • The difference of bone age (BA) and chronological age (CA) is within -2 to +2.
  • IGF-1 concentration is between -2 SDS to +2 SDS.
  • Prepubertal Status(Tanner Stage I).
  • Birth weight within the normal range.
  • Growth hormone treatment-naive.
  • Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

  • Subjects with abnormal liver and kidney functions (ALT > upper limit of normal value; Cr > upper limit of normal value).
  • Subjects are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
  • Subjects with known highly allergic constitution or allergy to investigational product or its excipient.
  • Subjects with systemic chronic disease and immune deficiency.
  • Patients diagnosed with tumor.
  • Patients with mental disease.
  • Patients with other types of abnormal growth and development.

    1. Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
    2. Turner syndrome (confirmed by karyotype test of girls);
    3. Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the patients, for both male and female patients);
    4. Laron sydrome (confirmed by IGF-1 generation test);
    5. Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old).
  • Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
  • Congenital skeletal abnormalities or scoliosis, claudication.
  • Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes).
  • Subjects with abnormal electrolyte, blood gas analysis (vein), creatine kinase.
  • Subjects who took part in other clinical trials within 3 months.
  • Subjects who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.).
  • For patients with potential high tumor risks such as tumor markers exceed normal range and some other relative information, they may be excluded from the treatment.
  • Other conditions which is inappropriate for this study in the opinion of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03221088
Other Study ID Numbers  ICMJE GenSci 033 CT-one year
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeneScience Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE GeneScience Pharmaceuticals Co., Ltd.
Collaborators  ICMJE
  • Tongji Hospital
  • First Hospital of Jilin University
  • Affiliated Hospital of Jiangnan University
  • The First Affiliated Hospital with Nanjing Medical University
  • Shanghai Children's Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • Children's Hospital of Fudan University
Investigators  ICMJE
Principal Investigator: Xiaoping Luo Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
PRS Account GeneScience Pharmaceuticals Co., Ltd.
Verification Date July 2017

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