Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

June 13, 2017 updated by: GeneScience Pharmaceuticals Co., Ltd.

Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Study Overview

Status

Status

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

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 (Anticipated)

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.
900

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 4

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
      • Chongqing, China
        • Recruiting
        • Southwest Hospital, Third Military Medical University
        • Contact:
          • Wei Liao, MD
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:
          • Xiaodong Huang, MD
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Deyun Liu, MD
      • Wuhu, Anhui, China
        • Recruiting
        • Wuhu No.1 People's Hospital
        • Contact:
          • Jiayan Pan, MD
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Qun Lian, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
          • Li Liu, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Shunye Zhu, MD
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Dan Lan, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Children's Hospital
        • Contact:
          • Hong Yu, MD
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • Lizhi Cao, MD
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Xingxing Zhang, MD
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Children's Hospital of Changchun
        • Contact:
          • Jing Liu, MD
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Junhua Dong, MD
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Children's Hospital of Shandong University
        • Contact:
          • Dongmei Zhao, MD
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Chengdu Women and Children's Central Hospital
        • Contact:
          • Xinran Cheng, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Xiaoming Luo, MD
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Children's Hospital ,Zhejiang University School of Medicine
        • Contact:
          • Junfen Fu, PhD
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Mingjuan Dai, MD
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
        • Contact:
          • Qin Dong
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Women and Children's Hospital
        • Contact:
          • Jianping Zhang, MD
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shaoxing Second Hospital
        • Contact:
          • Manyan Zhang, MD
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Xianjiang Jin, MD

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

10 months to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
  • According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
  • Height velocity (HV) ≤5.0 cm/yr.
  • GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
  • Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
  • Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
  • The child did not receive the treatment of growth hormone within 6 months.
  • Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Exclusion Criteria:

  • The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
  • The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
  • The child is known as hypersensitivity to PEG Somatropin.
  • The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
  • The child has potential tumor (family history).
  • The child has diabetics.
  • The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
  • The child took part in other clinical trials within 3 months.
  • Other conditions are excluded when the investigator preclude the 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: None (Open Label)

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: PEG-somatropin
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Biological: PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Experimental: PEG-Somatropin
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
Biological: PEG-somatropin
High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Biological: PEG-somatropin
Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

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
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
Time Frame: 26 weeks
HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age
26 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
HtSDSBA
Time Frame: 26 weeks
HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender
26 weeks
Annual height velocity
Time Frame: 26 weeks
Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
26 weeks
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)
Time Frame: 26 weeks
IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age
26 weeks
Bone Maturation
Time Frame: 26 weeks
Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)
26 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.
First People's Hospital of Hangzhou
Xiangya Hospital of Central South University
Southwest Hospital, China
Qilu Hospital of Shandong University
Shanghai Children's Medical Center
Third Affiliated Hospital, Sun Yat-Sen University
Second Affiliated Hospital of Wenzhou Medical University
Central South University
Zhejiang Provincial People's Hospital
Shaoxing Second Hospital
The Second Hospital of Anhui Medical University
Guangzhou Women and Children's Medical Center
The Children's Hospital of Zhejiang University School of Medicine
The First Affiliated Hospital of Xiamen University
First Affiliated Hospital of Guangxi Medical University
Zhejiang Provincial Hospital of TCM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junfen Fu, PhD, 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

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.
November 1, 2014

Primary Completion (Anticipated)

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.
June 1, 2017

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).
September 19, 2016

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.
September 20, 2016

First Posted (Estimate)

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.
September 21, 2016

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.
June 14, 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.
June 13, 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.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

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 004 CT-Zhejiang

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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