Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.

Condition or disease Intervention/treatment Phase
Dwarfism Drug: Jintrolong® low dose group Drug: Jintrolong® high dose group Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism

Arm Intervention/treatment
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.
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

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.
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

No Intervention: Negative control group
Untreated Control Group



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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]



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.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03221088


Contacts
Layout table for location contacts
Contact: Yanlin Chen +86-60871786-8197 chenyanlin@gensci-china.com

Locations
Layout table for location information
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China
Contact: Xiaoping Luo, PhD         
China, Jiangsu
The First Affiated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Yuhua Hu, MD         
Affiliated Hospital of Jiangnan University Recruiting
Wuxi, Jiangsu, China
Contact: Zhuangjian Xu, MD         
China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China
Contact: Hongwei Du, MD         
China, Zhejiang
The Children's Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Junfen Fu, MD         
China
Shanghai Children's Hospital of Fudan University Recruiting
Shanghai, China
Contact: Feihong Luo, MD         
Shanghai Children's Hospital Recruiting
Shanghai, China
Contact: Pin Li, MD         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
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
Layout table for investigator information
Principal Investigator: Xiaoping Luo Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Layout table for additonal information
Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03221088     History of Changes
Other Study ID Numbers: GenSci 033 CT-one year
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases