A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD

March 31, 2017 updated by: GeneScience Pharmaceuticals Co., Ltd.

A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)

This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical study.

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.
180

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Hui Pan, Doctor
      • Chongqing, China
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Wei Ren, Doctor
      • Chongqing, China
        • Not yet recruiting
        • Chongqing Three Gorges Central Hospital
        • Contact:
          • Yong Luo, Doctor
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Songjun Zhang, Doctor
      • Shijiazhuang, Hebei, China, 050057
        • Not yet recruiting
        • Heibei General Hospital
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Not yet recruiting
        • The Affiliated Hospital of Soochow University
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ling Jiang, Doctor
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Zhenmei An, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Wei Gu, Doctor

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Before the treatment, the subject should be diagnosed as AGHD based on medical history, clinical symptoms, vital signs, insulin tolerance test and imagological examinations.

    • The subject is diagnosed as GHD during childhood and remains as GHD in adulthood, and the linear growth has completed: bone age (BA) ≥18 years old; or the AGHD patient who experiences paroxysm after 18 years old: such as patients who have experienced pituitary surgeries (2 years after pituitary adenoma surgery, 5 years after craniopharyngioma surgery and 12 months after other pituitary surgeries), traumatic brain injury (TBI), Sheehan syndrome, and etc..
    • The plasma GH concentration peak is <5ng/ml in insulin tolerance test (ITT) (it's unnecessary to conduct ITT in the following conditions: anterior pituitary dysfunction, pituitary hormone deficiency (more than 3 hormones) and serum IGF-1 level below lower limit of normal value: i.e. -2 SD).
  • Age: 18-60 years old.
  • Patients with no history of GH treatment for more than one year.
  • Body mass index (BMI): 18.5 kg/m2≤BMI≤30kg/m2.
  • When there is other hormones deficiency (such as glucocorticoids, thyroid hormones and sex steroids), the subject should have received other hormone replacement therapies and the therapeutic dose shall be stable within 3 months before the enrolment.
  • The subject agrees to cooperate and complete the concerted trial procedures such as follow-ups, treatment plan and laboratory examinations, and sign the written informed consent.

Exclusion Criteria:

  • Patients with serious heart diseases, including NYHA III or above, serious arrhythmia, unstable angina pectoris or myocardial infarction within the latest 6 months.
  • Patients with a history of ischemic cerebrovascular disease, febrile convulsion and epilepsy seizures.
  • Patients with carpal tunnel syndrome.
  • Patients with poor hypertension control (systolic pressure>140mmHg or diastolic pressure >90mmHg under treatment).
  • Patients with previous or present history of malignant tumor: two or more direct relatives within three generations have previous or present history of tumor.
  • Patients undergoing anti-depressive therapy, immunosuppressive therapy, chemotherapy and radiotherapy (or with a history of radiotherapy).
  • Patients who have ever taken antiobesity drug within the latest 3 months.
  • Patients with serious infection.
  • Patients with consciousness disorders and mental diseases.
  • Subjects with impaired glucose regulation (IGR) (impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes; patients with a family history of diabetes (direct relatives).
  • Subjects with abnormal liver and kidney functions (ALT > 2 times of upper limit of normal value; eGFR calculated by MDRD formula <60).
  • Subjects positive for anti-HBc, HBsAg or HBeAg in Hepatitis B virus tests.
  • Subjects with highly allergic constitution or allergy to proteins or investigational productorits excipient in this study.
  • Subjects who took part in other clinical trials within 3 months.
  • Patients with other mental or physical deficiencies that influence the evaluation of investigational product.
  • Pregnant or lactating women; females planning to get pregnant within one year.
  • Subjects whose tumor markers exceed the upper limit of normal range and the re-examination result is still high.
  • Other conditions which is unsuitable for the 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

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-rhGH-1
Pegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The first stage, 1-2mg/2-4mg, subcutaneous injection,weekly, 26 weeks.
Drug: Somatropin Injection
Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.
Other Names:
  • Recombinant human growth hormone injection
EXPERIMENTAL: PEG-rhGH-2
Pegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The second stage (extension period study), maximum ≤4mg/w (24IU/w), 52 weeks.
Drug: Somatropin Injection
Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.
Other Names:
  • Recombinant human growth hormone injection

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
Fat mass change
Time Frame: 52 weeks
Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value
52 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
Lean body mass change
Time Frame: 52 weeks
Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value
52 weeks
Blood lipid change
Time Frame: 52 weeks
Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value
52 weeks
Waist circumference change
Time Frame: 52 weeks
Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value
52 weeks
Percentage of body fat change
Time Frame: 52 weeks
Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value
52 weeks
Cardiac function change
Time Frame: 52 weeks
Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value
52 weeks
Cardiac structure change
Time Frame: 52 weeks
Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value
52 weeks
IGF-1 change
Time Frame: 52 weeks
Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value
52 weeks
Grip change
Time Frame: 52 weeks
Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement.
52 weeks
Quality of life change
Time Frame: 52 weeks
Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment
52 weeks
Waist-hip ratio change
Time Frame: 52 weeks
Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment
52 weeks
Cardiac structure change
Time Frame: 52 weeks
Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value
52 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.
Peking University First Hospital
Peking Union Medical College Hospital
The Second Hospital of Hebei Medical University
West China Hospital
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hebei General Hospital
The First Affiliated Hospital of Soochow University
First Affiliated Hospital of Chongqing Medical University
Chongqing Three Gorges Central Hospital

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: Hui Pan, Doctor, Peking Union Medical College Hospital

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 (ANTICIPATED)

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.
April 1, 2017

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.
February 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

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).
March 28, 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.
March 31, 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.
April 7, 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.
April 7, 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.
March 31, 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.
March 1, 2017

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 034 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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