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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03104010
Other study ID # GenSci 034 CT
Secondary ID
Status Recruiting
Phase Phase 2
First received March 28, 2017
Last updated March 31, 2017
Start date April 2017
Est. completion date September 2022

Study information

Verified date March 2017
Source GeneScience Pharmaceuticals Co., Ltd.
Contact Xiaohua Feng, MD
Phone 0431-85170552
Email fengxiaohua@gensci-china.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date September 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing
China West China Hospital, Sichuan University Chengdu Sichuan
China Chongqing Three Gorges Central Hospital Chongqing
China The First Affiliated Hospital of Chongqing Medical University Chongqing
China The Second Affiliated Hospital of Zhejiang University school of medicine Hangzhou Zhejiang
China Qilu Hospital of Shandong University Jinan Shandong
China Heibei General Hospital Shijiazhuang Hebei
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China The Affiliated hospital of soochow University Suzhou Jiangsu

Sponsors (11)

Lead Sponsor Collaborator
GeneScience Pharmaceuticals Co., Ltd. Chongqing Three Gorges Central Hospital, First Affiliated Hospital of Chongqing Medical University, Hebei General Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Qilu Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital of Soochow University, The Second Hospital of Hebei Medical University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat mass change Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value 52 weeks
Secondary Lean body mass change Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value 52 weeks
Secondary Blood lipid change Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value 52 weeks
Secondary Waist circumference change Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value 52 weeks
Secondary Percentage of body fat change Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value 52 weeks
Secondary Cardiac function change Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value 52 weeks
Secondary Cardiac structure change Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value 52 weeks
Secondary IGF-1 change Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value 52 weeks
Secondary Grip change Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement. 52 weeks
Secondary Quality of life change Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment 52 weeks
Secondary Waist-hip ratio change Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment 52 weeks
Secondary Cardiac structure change Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value 52 weeks
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