EUCTR2013-002892-16-DE进行中（未招募）1 期
A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period - REAL 1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
- •2. hGH treatment naïve or no exposure to hGH or GH secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of GHD, subjects can be included)
- •3. If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
- •4. FOR ALL COUNTRIES EXCEPT JAPAN:
- •- Confirmed diagnosis of adult growth hormone deficiency. Subjects must satisfy at least one of the following criteria, and documentation of test results must be available before randomisation (either from subject´s file or new test):
- •a. Insulin tolerance test (ITT) or glucagon test: a peak GH response of < 3 ng/mL (3 µg/L)
- •b. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI)
- •i. BMI< 25 kg/m^2, a peak GH < 11 ng/mL (µg/L)
- •ii. BMI 25–30 kg/m^2, a peak GH < 8 ng/mL (8 µg/L)
- •iii. BMI > 30 kg/m^2, a peak GH < 4 ng/mL (4 µg/L )
- •c. Three or more pituitary hormone deficiencies and IGF-I SDS < -2.0
- •FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset AGHD need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):
- •a. ITT test: a peak GH of = 1.8 ng/mL (assay using recombinant GH standard)
- •b. glucagon test: a peak GH of = 1.8 ng/mL (assay using recombinant GH standard)
- •c. GHRP-2 tolerance test: a peak GH of = 9 ng/mL (assay using recombinant GH standard)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:
- •a) Resection of in situ carcinoma of the cervix uteri
- •b) Complete eradication of squamous cell or basal cell carcinoma of the skin
- •Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject’s file
研究者
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