EUCTR2017-004208-24-BEActive, not recruitingPhase 1
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)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is
- •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.
- •Adequate liver biopsy sample for evaluation by a central reader.
- •Presence of NASH as demonstrated by histologic evidence based on liver
- •biopsy - NASH with fibrosis stage F2/F3, demonstrated on liver biopsy
- •with evaluation by central reading during the screening period.
- •Alternatively, a historical biopsy can be used if performed within 6
- •months prior to screening and evaluated by a central reader, 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
Exclusion Criteria
- •Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or any other FXR agonist.
- •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 screening (subjects documented to be assigned to placebo in such trials may be eligible immediately following completion of their participation in the previous trial).
- •Patients taking medications prohibited by the protocol.
- •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 modified AUDIT questionnaire = 8
- •Uncontrolled diabetes defined as glycated hemoglobin (HbA1c) = 9% at screening
- •Patients who are not candidates for liver biopsy
- •Presence of cirrhosis on liver biopsy or medical history
Investigators
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