NCT03104010Unknown2 期
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 180
- 试验地点
- 9
- 主要终点
- Fat mass change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Somatropin Injection (Drug)
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.
干预措施: Somatropin Injection (Drug)
结局指标
主要结局
Fat mass change
时间窗: 52 weeks
Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value
次要结局
- Cardiac function change(52 weeks)
- Lean body mass change(52 weeks)
- Blood lipid change(52 weeks)
- Waist circumference change(52 weeks)
- Percentage of body fat change(52 weeks)
- Cardiac structure change(52 weeks)
- IGF-1 change(52 weeks)
- Grip change(52 weeks)
- Quality of life change(52 weeks)
- Waist-hip ratio change(52 weeks)
研究者
研究点 (9)
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