A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

December 10, 2017 updated by: GeneScience Pharmaceuticals Co., Ltd.

Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)

To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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
      • Beijing, China
        • Beijing Children's Hospital of Capital Medical University
      • Shanghai, China
        • Shanghai Children's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital with Nanjing Medical Universit
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Children's Hospital of 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of small for gestational age, SGA.
  • Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
  • Prepubertal stage (Tanner I).
  • Without catch-up growth in two years after birth.
  • Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
  • A GH peak concentration >10µg/L in a provocative test within a year before participate in the study.
  • Bone age<Chronological age+1.
  • Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L and 2-hour postprandial blood glucose< 7.8mmol/L.
  • Gestational age≥Gestational age≥ 36weeks + 4days.
  • Never accepted growth hormone treatment.
  • The subjects and their guardians signed informed consent.

Exclusion Criteria:

  • Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value).
  • Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
  • Known highly allergic constitution or allergic to the test drug.
  • Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
  • Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
  • Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
  • Other conditions which in the opinion of the investigator preclude enrollment into the study.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses.
Biological: Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
Biological: Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose
Experimental: Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided doses.
Biological: Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
Biological: Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Height standard deviation score for chronological age (Ht SDSCA)
Time Frame: 26 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
26 weeks
Height standard deviation score for chronological age (Ht SDSCA)
Time Frame: 52 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
52 weeks
Height standard deviation score for chronological age (Ht SDSCA)
Time Frame: 78 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
78 weeks
Height standard deviation score for chronological age (Ht SDSCA)
Time Frame: 104 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
104 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ΔHtSDSCA
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in height SDS for chronological age (Ht SDSCA)
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in HV
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in annualized height velocity (HV)
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in bone age maturation
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in mole ratio of IGF-1 and IGFBP-3
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in PAH
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
Change in prediction of adult height (PAH)
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in obesity prevalence
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in overweight
Time Frame: 26 weeks， 52 weeks，78 weeks and 104 weeks
26 weeks， 52 weeks，78 weeks and 104 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GeneScience Pharmaceuticals Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Tongji Hospital
Shanghai Children's Hospital
Beijing Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GenSci 030 CT-II

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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