Clinical Trial Details

Trial ID: L0229
Source ID: NCT03517540
Associated Drug: Tropifexor
Title: Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
Acronym: TANDEM
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03517540/results
Conditions: Non-alcoholic Steatohepatitis (NASH)
Interventions: Drug: Tropifexor (LJN452)|Drug: Cenicriviroc (CVC)
Outcome Measures: Number of Participants With Adverse Events|Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis|Proportion of Participants With Resolution of Steatohepatitis
Sponsor/Collaborators: Novartis Pharmaceuticals|Allergan|Novartis
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 193
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: September 11, 2018
Completion Date: October 15, 2020
Results First Posted: November 12, 2021
Last Update Posted: January 24, 2022
Locations: Novartis Investigative Site, Chandler, Arizona, United States|Novartis Investigative Site, North Little Rock, Arkansas, United States|Novartis Investigative Site, Coronado, California, United States|Novartis Investigative Site, Los Angeles, California, United States|Novartis Investigative Site, Los Angeles, California, United States|Novartis Investigative Site, Pasadena, California, United States|Novartis Investigative Site, Rialto, California, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Marietta, Georgia, United States|Novartis Investigative Site, Chicago, Illinois, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Metairie, Louisiana, United States|Novartis Investigative Site, Shreveport, Louisiana, United States|Novartis Investigative Site, Concord, North Carolina, United States|Novartis Investigative Site, Durham, North Carolina, United States|Novartis Investigative Site, Morehead City, North Carolina, United States|Novartis Investigative Site, Providence, Rhode Island, United States|Novartis Investigative Site, Chattanooga, Tennessee, United States|Novartis Investigative Site, Germantown, Tennessee, United States|Novartis Investigative Site, Hermitage, Tennessee, United States|Novartis Investigative Site, Dallas, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Murray, Utah, United States|Novartis Investigative Site, Richmond, Virginia, United States|Novartis Investigative Site, Richmond, Virginia, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Florencio Varela, Buenos Aires, Argentina|Novartis Investigative Site, Edegem, Antwerpen, Belgium|Novartis Investigative Site, Leuven, Belgium|Novartis Investigative Site, Vancouver, British Columbia, Canada|Novartis Investigative Site, Toronto, Ontario, Canada|Novartis Investigative Site, Toronto, Ontario, Canada|Novartis Investigative Site, Chicoutimi, Quebec, Canada|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Prague, Czechia|Novartis Investigative Site, Shebeen El-Kom, Egypt|Novartis Investigative Site, Paris Cedex 13, France|Novartis Investigative Site, Pessac Cedex, France|Novartis Investigative Site, Strasbourg, France|Novartis Investigative Site, Mainz, Germany|Novartis Investigative Site, Wuerzburg, Germany|Novartis Investigative Site, New Delhi, Delhi, India|Novartis Investigative Site, Tel Aviv, Israel|Novartis Investigative Site, Modena, Itlay, Italy|Novartis Investigative Site, Palermo, PA, Italy|Novartis Investigative Site, Roma, RM, Italy|Novartis Investigative Site, Verona, VR, Italy|Novartis Investigative Site, Milan, Italy|Novartis Investigative Site, Riga, Latvia|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, Singapore, Singapore|Novartis Investigative Site, Singapore, Singapore|Novartis Investigative Site, Santander, Cantabria, Spain|Novartis Investigative Site, Barcelona, Catalunya, Spain|Novartis Investigative Site, Barcelona, Catalunya, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain|Novartis Investigative Site, Izmir, Turkey|Novartis Investigative Site, Pendik / Istanbul, Turkey|Novartis Investigative Site, High Heaton, Newcastle Upon Tyne, United Kingdom|Novartis Investigative Site, Aberdeen, United Kingdom|Novartis Investigative Site, Torquay, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03517540

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D379 Tropifexor Chemical drug DB16343 FXR agonist Enhance lipid metabolism Under clinical trials Details
D068 Cenicriviroc Chemical drug DB11758 CCR2 inhibitor; CCR5 inhibitor Anti-fibrosis Failed in clinical trials Details