Study of safety, tolerability, and efficacy of a combination treatment of tropifexor and cenicriviroc in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis
- Conditions
- on-alcoholic Steatohepatitis (NASH)MedDRA version: 20.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-004208-24-CZ
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 193
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). 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the safety and tolerability of tropifexor + CVC in patients with NASH with fibrosis stage F2/F3 by monitoring adverse events, vital signs and laboratory values<br>during 48 weeks of treatment as compared to monotherapy with each of tropifexor and CVC;Secondary Objective: To characterize the efficacy of different doses of the combination drug tropifexor + CVC in patients with NASH with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment<br>compared to monotherapies (tropifexor and CVC) compared to baseline biopsy.;Primary end point(s): Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory values over 48 weeks of treatment;Timepoint(s) of evaluation of this end point: 48 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of patients who have at least a one point improvement in fibrosis<br><br>Proportion of patients with resolution of steatohepatitis;Timepoint(s) of evaluation of this end point: 48 weeks