A randomized, double-blind, multicenter study to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (TANDEM). -

OVARTIS PHARMA AG0 个研究点目标入组 200 人开始时间: 2020年11月4日最近更新: 2020年12月7日

研究概览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed.
•2. Male and female patients 18 years or older (at the time of the screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440 lb) to participate in the study.
•3. Adequate liver biopsy sample for evaluation by a central reader.
•4. Presence of NASH as demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3, demonstrated on liver biopsy during the screening period. Alternatively, a historical biopsy can be used if performed within 6 months prior to screening, if:
•- the patient has been receiving any of the therapies listed in Table 5-4, the dose must have been stable (since 1 month before the biopsy up to and including screening),
•- the patient’s weight has been stable (maximum weight loss of 10% since biopsy up to and including screening).
•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 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•1. Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or any other FXR agonist.
•2. Participated in a clinical trial and treated with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening (subjects documented to be assigned to placebo in such trials may be eligible immediately following completion of their participation in the previous trial).
•3. Patients taking medications prohibited by the protocol. An overview of prohibited medications is given in Table 5-2, and the summary of medications permitted only if on stable dose is in Table 5-4
•4. Current or history of significant alcohol consumption for a period ofmore 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 modified AUDIT questionnaire = 8
•5. Uncontrolled diabetes defined as glycated hemoglobin (HbA1c) = 9% at screening
•6. Patients who are not candidates for liver biopsy
•7. Presence of cirrhosis on liver biopsy or medical history

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