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Clinical trial

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)

Read time: 3 mins
Last updated:11th Sep 2018
Identifier: NCT03517540

The purpose of this study is 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: September 11, 2018
Estimated Primary Completion Date: July 28, 2020
Estimated Study Completion Date: September 2, 2020

Arms:
- Experimental:
Arm A: Tropifexor (LJN452) - Dose 1
- Experimental: Arm B: Cenicriviroc (CVC)
- Experimental: Arm C: Tropifexor (LJN452) Dose 1 + CVC
- Experimental: Arm D: Tropifexor Dose 2 + CVC

Category Value
Date last updated at source 2019-07-18
Study type(s) Interventional
Expected enrolment 200
Study start date 2018-09-11
Estimated primary completion date 2020-07-28

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