Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis (TANDEM)
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| ClinicalTrials.gov Identifier: NCT03517540 |
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Recruitment Status :
Completed
First Posted : May 7, 2018
Results First Posted : November 12, 2021
Last Update Posted : April 29, 2022
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Sponsor:
Novartis Pharmaceuticals
Collaborator:
Allergan
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Non-alcoholic Steatohepatitis (NASH) |
| Interventions |
Drug: Tropifexor (LJN452) Drug: Cenicriviroc (CVC) |
| Enrollment | 193 |
Participant Flow
| Recruitment Details | 193 participants enrolled at 65 sites in 17 countries |
| Pre-assignment Details | 450 of 643 subjects discontinued during screening phase |
| Arm/Group Title | Arm A: Tropifexor (LJN452) - Dose 1 | Arm B: Cenicriviroc (CVC) | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Arm D: Tropifexor Dose 2 + CVC |
|---|---|---|---|---|
 Arm/Group Description |
tropifexor 140 mg, once daily | CVC 150 mg, once daily | tropifexor 140 mg + CVC 150 mg, once daily | tropifexor 90 mg + CVC 150 mg, once daily |
| Period Title: Overall Study | ||||
| Started | 50 | 48 | 47 | 48 |
| Completed | 36 | 41 | 38 | 43 |
| Not Completed | 14 | 7 | 9 | 5 |
| Reason Not Completed | ||||
| Protocol Violation | 2 | 0 | 0 | 1 |
| Adverse Event | 9 | 3 | 8 | 1 |
| Withdrawal by Subject | 3 | 4 | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | Arm A: Tropifexor (LJN452) - Dose 1 | Arm B: Cenicriviroc (CVC) | Arm C: Tropifexor (LJN452) Dose 1 + CVC | Arm D: Tropifexor Dose 2 + CVC | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
tropifexor 140 mg, once daily | CVC 150 mg, once daily | tropifexor 140 mg + CVC 150 mg, once daily | tropifexor 90 mg + CVC 150 mg, once daily | Total of all reporting groups | |
| Overall Number of Baseline Participants | 50 | 48 | 47 | 48 | 193 | |
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Baseline Analysis Population Description |
Full analysis set (FAS) - All participants to whom study treatment was assigned (excluding patients who were mis-randomized and did not take investigational drug. Mis-randomized participants were those who were not qualified for randomization but were inadvertently randomized into the study). Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 50 participants | 48 participants | 47 participants | 48 participants | 193 participants | |
| 54.8 (13.35) | 53.7 (11.79) | 54.7 (12.65) | 54.9 (12.29) | 54.5 (12.52) | ||
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 50 participants | 48 participants | 47 participants | 48 participants | 193 participants |
| <65 |
35 70.0%
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39 81.3%
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37 78.7%
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38 79.2%
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149 77.2%
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| >=65 |
15 30.0%
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9 18.8%
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10 21.3%
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10 20.8%
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44 22.8%
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Sex/Gender, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 50 participants | 48 participants | 47 participants | 48 participants | 193 participants |
| Male |
20 40.0%
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17 35.4%
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18 38.3%
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25 52.1%
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80 41.5%
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| Female |
30 60.0%
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31 64.6%
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29 61.7%
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23 47.9%
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113 58.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 50 participants | 48 participants | 47 participants | 48 participants | 193 participants |
| White |
41 82.0%
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44 91.7%
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40 85.1%
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43 89.6%
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168 87.0%
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| Asian |
7 14.0%
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4 8.3%
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5 10.6%
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5 10.4%
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21 10.9%
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| Black |
1 2.0%
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0 0.0%
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2 4.3%
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0 0.0%
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3 1.6%
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| Unknown |
1 2.0%
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0 0.0%
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0 0.0%
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0 0.0%
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1 0.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | +1 (862) 778-8300 |
| EMail: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT03517540 |
| Other Study ID Numbers: |
CLJC242A2201J 2017-004208-24 ( EudraCT Number ) LJC242A2201J ( Other Identifier: Novartis ) |
| First Submitted: | April 9, 2018 |
| First Posted: | May 7, 2018 |
| Results First Submitted: | October 14, 2021 |
| Results First Posted: | November 12, 2021 |
| Last Update Posted: | April 29, 2022 |