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

Adult Growth Hormone Deficiency Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03104010
• Other study ID #: GenSci 034 CT
• 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
• 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.

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases

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