Adult Growth Hormone DeficiencyPhase 2NCT03104010
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
A Phase 2 study testing Somatropin Injection in people with Adult Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- Somatropin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 9 sitesChina
- Study dates
- Apr 2017to Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Hui Pan, Doctor
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Zhenmei An, Doctor
- Not yet recruiting
Chongqing Three Gorges Central Hospital
Chongqing
Yong Luo, Doctor
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Wei Ren, Doctor
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang
Wei Gu, Doctor
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Ling Jiang, Doctor
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Songjun Zhang, Doctor
- Not yet recruiting
Heibei General Hospital
Shijiazhuang, Hebei, 050057
- Not yet recruiting
The Affiliated hospital of soochow University
Suzhou, Jiangsu
About this study
Official title: 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.
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- Somatropin Injection
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin InjectionDrug
Also called Recombinant human growth hormone 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.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhGH-1 | Experimental | Pegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The first stage, 1-2mg/2-4mg, subcutaneous injection,weekly, 26 weeks. Receives: Drug: Somatropin Injection |
| PEG-rhGH-2 | Experimental | 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. Receives: Drug: Somatropin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass change
Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value
Measured: 52 weeks
Secondary outcomes (11)
Lean body mass change
Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value
Measured: 52 weeks
Blood lipid change
Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value
Measured: 52 weeks
Waist circumference change
Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value
Measured: 52 weeks
Percentage of body fat change
Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value
Measured: 52 weeks
Cardiac function change
Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value
Measured: 52 weeks
Cardiac structure change
Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value
Measured: 52 weeks
IGF-1 change
Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value
Measured: 52 weeks
Grip change
Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement.
Measured: 52 weeks
Quality of life change
Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment
Measured: 52 weeks
Waist-hip ratio change
Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment
Measured: 52 weeks
Cardiac structure change
Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, Peking University First Hospital, Hebei General Hospital, The Second Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, The First Affiliated Hospital of Soochow University, First Affiliated Hospital of Chongqing Medical University, Chongqing Three Gorges Central Hospital, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Hui Pan, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104010
- Sponsor's protocol ID
- GenSci 034 CT
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)
- ClinicalTrials.gov ID
- NCT03104010
- Acronym / sponsor ID
- GenSci 034 CT
- Conditions
- Adult Growth Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, Peking University First Hospital, Hebei General Hospital, The Second Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, The First Affiliated Hospital of Soochow University, First Affiliated Hospital of Chongqing Medical University, Chongqing Three Gorges Central Hospital, West China Hospital
- Study start
- Apr 2017 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhGH-1 | Experimental | Drug: Somatropin InjectionPegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The first stage, 1-2mg/2-4mg, subcutaneous injection,weekly, 26 weeks. |
| PEG-rhGH-2 | Experimental | Drug: Somatropin InjectionPegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The second stage (extension period study), maximum ≤4mg/w (24IU/w), 52 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Before the treatment, the subject should be diagnosed as AGHD based on medical history, clinical symptoms, vital signs, insulin tolerance test and imagological examinations.
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin InjectionAlso: Recombinant human growth hormone injectionRecombinant 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. | Drug | PEG-rhGH-1, PEG-rhGH-2 |
Primary outcome
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
11 secondary outcomes
Lean body mass change
Time frame: 52 weeks
Blood lipid change
Time frame: 52 weeks
Waist circumference change
Time frame: 52 weeks
Percentage of body fat change
Time frame: 52 weeks
Cardiac function change
Time frame: 52 weeks
Cardiac structure change
Time frame: 52 weeks
IGF-1 change
Time frame: 52 weeks
Grip change
Time frame: 52 weeks
Quality of life change
Time frame: 52 weeks
Waist-hip ratio change
Time frame: 52 weeks
Cardiac structure change
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Pan, Doctor principal investigator
Peking Union Medical College Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin Injection in people with Adult Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Feng, MD (0431-85170552, fengxiaohua@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass change (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.