EUCTR2015-005215-33-BE进行中（未招募）1 期
A randomized, double-blind, placebo controlled, 3- part, adaptive design, multicenter study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with non-alcoholic steatohepatitis (NASH) FLIGHT-FXR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 345
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
- •Written informed consent must be obtained before any assessment is performed
- •Male and female patients 18 years or older (at the time of the screening visit)
- •Diagnosis of NASH:
- •Parts A&B:
- •Presence of NASH as demonstrated by ONE of the following:
- •- Histologic evidence of NASH based on liver biopsy obtained 2 years or less before randomization with a diagnosis consistent with NASH, fibrosis level F1, F2 or F3, (i.e. fibrosis in the absence of established cirrhosis) no diagnosis of alternative chronic liver diseases
- •Part C (All patients): Adequate liver biopsy sample for evaluation by Central Reader to confirm Histologic evidence of NASH based on liver
- •biopsy obtained during the Screening period or within 6 months before randomization with a diagnosis consistent with NASH, fibrosis level F2 or
- •F3, and no diagnosis of alternative chronic liver diseases. Permitted therapy must be stable as outlined in Table 5-5 (from 1 month prior to biopsy up to and including screening)
- •AND (all parts)
- •ALT = 43 IU/L (males) or = 28 IU/L (females)
- •OR (for Parts A and B only)
- •Phenotypic diagnosis of NASH based on presence of ALL THREE of the following:
- •o ALT = 43 IU/L (males) or = 28 IU/L (females) AND
- •o BMI = 27 kg/m2 (in patients with a self-identified race other than Asian) or =23 kg/m2 (in patients with a self-identified Asian race)
- •o Diagnosis of Type 2 diabetes mellitus by having either:
- •- HbA1C = 6.5% or
- •- Drug therapy for Type 2 diabetes mellitus
- •Liver fat = 10% at screening as determined by the central MRI laboratory
- •Patients must weigh at least 40 kg (88 lb) and no more than 150 kg (330 lb) to participate in the study
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 155
排除标准
- •Previous exposure to an FXR agonist including tropifexor
- •Patients taking medications prohibited by the protocol
- •Pregnant or nursing (lactating) women
- •Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average) and/or a score on the AUDIT questionnaire =8
- •Uncontrolled diabetes defined as HbA1c = 9.5% within 60 days prior to enrollment
- •Presence of cirrhosis on liver biopsy or clinical diagnosis
- •Clinical evidence of hepatic decompensation or severe liver impairment
- •Previous diagnosis of other forms of chronic liver disease
- •Patients with contraindications to MRI imaging
研究者
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