Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
NCT ID: NCT03517540
Last Updated: 2022-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
193 participants
INTERVENTIONAL
2018-09-11
2020-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Tropifexor (LJN452) - Dose 1
tropifexor 140 mcg, once daily; given orally
Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Arm B: Cenicriviroc (CVC)
CVC 150 mg, once daily; given orally
Cenicriviroc (CVC)
Comparison with monotherapy and different combination doses
Arm C: Tropifexor (LJN452) Dose 1 + CVC
tropifexor 140 mcg + CVC 150 mg, once daily; given orally
Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Cenicriviroc (CVC)
Comparison with monotherapy and different combination doses
Arm D: Tropifexor Dose 2 + CVC
tropifexor 90 mcg + CVC 150 mg, once daily; given orally
Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Cenicriviroc (CVC)
Comparison with monotherapy and different combination doses
Interventions
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Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Cenicriviroc (CVC)
Comparison with monotherapy and different combination doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Adequate liver biopsy sample for evaluation by Central Reader. 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.
Exclusion Criteria
History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or 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.
Patients taking medications prohibited by the protocol. History of treated or untreated malignancy of any organ system, other than localized basal cell carcinoma of the skin or treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases .
Pregnant or nursing (lactating) women. Women of child-bearing potential. 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.
Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug abuse, within the last 6 months prior to randomization.
Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as HbA1c ≥ 9% at screening Clinical evidence of hepatic decompensation or severe liver impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver transplantation or planned liver transplant. Known positivity for HIV. History or current diagnosis of ECG abnormalities indicating significant risk of safety for the patient to participate.
History of inflammatory bowel disease. Patients who are not candidates for liver biopsy. Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients with an abnormal platelet count (referring to reference ranges from the central lab).
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chandler, Arizona, United States
Novartis Investigative Site
North Little Rock, Arkansas, United States
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Coronado, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Rialto, California, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Providence, Rhode Island, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Hermitage, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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CABA, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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San Juan Bautista, Buenos Aires, Argentina
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Edegem, Antwerpen, Belgium
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Leuven, , Belgium
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Prague, , Czechia
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Shebeen El-Kom, , Egypt
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Paris, , France
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Pessac, , France
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Strasbourg, , France
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Mainz, , Germany
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Würzburg, , Germany
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New Delhi, National Capital Territory of Delhi, India
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Tel Aviv, , Israel
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Modena, Itlay, Italy
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Palermo, PA, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Milan, , Italy
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Riga, , Latvia
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Moscow, , Russia
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Moscow, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Valencia, Valencia, Spain
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Pendik / Istanbul, Turkey, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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High Heaton, Newcastle Upon Tyne, United Kingdom
Novartis Investigative Site
Aberdeen, , United Kingdom
Novartis Investigative Site
Torquay, , United Kingdom
Countries
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References
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Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. Contemp Clin Trials. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Epub 2019 Nov 13.
Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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2017-004208-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LJC242A2201J
Identifier Type: OTHER
Identifier Source: secondary_id
CLJC242A2201J
Identifier Type: -
Identifier Source: org_study_id
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