Table Info

Table 1.

Registered ongoing clinical trials on CVC in patients with NAFLD

ID, registration date (DD/MM/YYYY)*	Title	Design	Arms	Patients (n)	Duration	Primary outcome(s)
NCT03517540 09/04/2018 OR EUCTR2017-004208 24 21/06/2018 OR CTRI/2019/01/017014 09/01/2019	A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and CVC in Adult Patients With NASH and Liver Fibrosis (TANDEM)	Multicenter, randomized, double-blind, phase 2	Tropifexor 140 μg vs. CVC 150 mg vs. Tropifexor 140 μg + CVC 150 mg vs. Tropifexor 90 μg + CVC 150 mg	200	12 months	Number of participants with adverse events
NCT03376841 2/8/2017	An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of CVC and Its Metabolites Following Single Dose Administration	Single-center, non-randomized, open label, phase 1	CVC (single dose; NA mg)	16	6 days	1) AUC from time 0 to time t (AUC_0-t) 2) AUC from time 0 to infinity (AUC_0-∞) 3) Maximum plasma drug concentration (C_max)
NCT03059446 3/2/2017	Open-label Rollover Study of CVC for the Treatment of Liver Fibrosis in Adult Subjects With NASH	Multicenter, single group, open label, phase 2	CVC 150 mg	560	24 months	Number of participants with adverse events
NCT03028740 13/1/2017 OR EUCTR2016-004566-26 22/02/2017 OR PER-041-17 02/04/2018	A Phase 3 Study to Evaluate the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adult Subjects With NASH (AURORA)	Multicenter, randomized, double-blind, phase 3	CVC 150 mg vs. placebo	2000	12 months (for endpoint #1); 60 months (for endpoint #2)	1) Improvement in fibrosis ≥1 stage without worsening of NASH 2) Composite outcome of all-cause mortality, cirrhosis, HCC, liver thransplantation and other liver-related events
NCT02342067 12/1/2015	A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of PGZ on the PK of CVC and the Effect of CVC on the PK of PGZ	Single-center, randomized, open-label, phase 1	CVC 150 mg, then PGZ 45 mg, then CVC + PGZ vs. PGZ 45 mg, then CVC 150 mg, then CVC + PGZ	20	40 days	PK Assessment of CVC and PGZ, as measured by C_max, C_min and AUC
NCT02330549 22/12/2014	Effect of CCR2 and CCR5 Antagonism by CVC on Peripheral and Adipose Tissue Insulin Sensitivity in Adult Obese Subjects With Prediabetes or Type 2 Diabetes Mellitus and Suspected NAFLD (ORION)	Multicenter, randomized, double-blind, phase 2	CVC 150 mg vs. placebo	45	6 months	Changes in insulin sensitivity (peripheral and adipose tissue)

References are presented in date of registration order (newer to older); AUC: area under the curve; C_max: maximum plasma drug concentration; C_min: minimum plasma drug concentration; NA: not available; PGZ: pioglitazone; PK: pharmacokinetics

Declarations

Author Contributions

MD, KP, AP: design of the review, drafting the manuscript; JK: design of the review, critical revision of the manuscript; SAP: conception and design of the review, drafting and critical revision of the manuscript; all the authors: final approval of the version to publish, agreeing to be accountable for all aspects of the work.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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