Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS

August 15, 2018 updated by: GeneScience Pharmaceuticals Co., Ltd.

Phase 2 Study of Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS (Idiopathic Short Stature): a 52-week Multicenter, Open-label, Randomized, Negative Controlled Study Followed by a 52-week Open-label Period

Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.

Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Children's Hospital of Fudan University
      • Shanghai, China
        • Recruiting
        • Children's Hospital of Shanghai
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Children's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Children's Hospital of Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Children's Hospital, Zhejiang University school of medicine

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

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Boys are between 4 and 10 years old age and girls are between 4 and 9 years old age;
  • Height <-2.25 SD (Standard deviation) for chronological age;
  • GH (Growth hormone) peak concentration ≥10.0 ng/mL in GH stimulation tests;
  • The bone age (BA) ≤chronological age (CA)+6 months;
  • Prepubertal Status (Tanner Stage I);
  • Birth weight within the normal range;
  • Growth hormone treatment-naive;
  • Participants are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

  • Participants with abnormal liver and kidney functions (ALT > upper limit 1.5 times of normal value; Cr > upper limit of normal value);
  • Participants are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
  • Participants with known highly allergic constitution or allergy to investigational product or its excipient;
  • Participants with systemic chronic disease and immune deficiency;
  • Participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment;
  • Participants with mental disease;

  • Participants 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 participants, for both male and female participants);
    4. Laron syndrome (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);
    6. Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
  • Participants with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes;
  • BMI (Body mass index) ≥22kg/m²;
  • Congenital skeletal abnormalities or scoliosis, claudication;
  • Participants who took part in other clinical trials within 3 months;
  • Participants who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.);
  • Other conditions which is inappropriate for this study in the opinion of the investigator.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: rhGH/Jintropin AQ
Jintropin AQ, injection, 30IU/10mg/3ml/cartridge, 0.05mg /kg/d in phase 1 and 0.05-0.07mg/kg/d in phase 2.
Other: Negative control
Untreated-control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
Time Frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age.
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

Secondary Outcome Measures

Outcome Measure
Time Frame
ΔHT (Change of height)
Time Frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
△BA/CA (bone age change / chronological age)
Time Frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Yearly growth velocity
Time Frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔIGF-1 SDS (Change of insulin-like growth factor 1 standard deviation score)
Time Frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.

Collaborators and Investigators

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

Sponsor

GeneScience Pharmaceuticals Co., Ltd.

Collaborators

The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital, Sun Yat-Sen University
Children's Hospital of Fudan University
Shanghai Children's Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
The Children's Hospital of Zhejiang University School of Medicine
Shanxi Provincial Maternity and Children's Hospital

Investigators

  • Principal Investigator: Junfen Fu, Doctor, The Children's Hospital of Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 11, 2018

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 30, 2021

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSci 046 CT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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