NCT02971033

Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C

Terminated Phase 2 Results posted Last updated 6 June 2022

What this trial tests

Phase 2 trial testing 20mg ezetimibe in Chronic Hepatitis C in 2 participants. Terminated before completion.

Timeline

16 April 2018

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2
Start date	16 April 2018
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across United States

Drugs / interventions tested

• 20mg ezetimibe — full drug profile →
• Placebo
• 40mg ezetimibe — full drug profile →

Conditions studied

• Chronic Hepatitis C — all drugs for Chronic Hepatitis C →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 70, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Viral Load Primary · 0 weeks, 8 weeks

Participants will have their HCV-RNA measured in international unit per milliliter at baseline and 8 weeks. HCV RNA international unit per milliliter ranges from 0 to infinity, with higher levels indicating HCV positivity. The change in international unit per milliliter will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day). Change is calculated based on 8 weeks minus baseline (0 weeks).

Group	Value	95% CI
Placebo	-4030000	-4030000 – -4030000
20mg/Day Ezetimibe	-5860000	-5860000 – -5860000

Second Phase Slope Primary · 3 days through 4 weeks

HCV declines in a biphasic manner under HCV treatment. Here we are measuring the slope (i.e., rate) at which HCV is declining during the second slower phase of viral decline.

Group	Value	95% CI
Placebo	.90	.90 – .90
20mg/Day Ezetimibe	.98	.98 – .98

Change in Alanine Aminotransferase (ALT) Secondary · 8 weeks

Participants will have their ALT levels measured in units per liter (U/L) at baseline and 8 weeks. ALT ranges from 0 to infinity with higher levels of ALT indicating hepatocyte death. The change in ALT levels will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day).

Group	Value	95% CI
Placebo	-75	-75 – -75
20mg/Day Ezetimibe	-73	-73 – -73

Sponsor's own description

To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers to viral resistance and strategies to shorten the current treatment duration, the goal is to develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of those inhibitors for treating HCV infection. The investigators recently discovered that a major cholesterol uptake receptor is required for HCV entry into hepatocytes and that there is already an FDA-approved drug that inhibits cholesterol uptake by this receptor. Importantly the same drug also potently blocks HCV entry in human liver cells both in cell culture and in a small animal model. Further, looking back at people who were previously treated for HCV infection, the investigators found treatment response to be better (i.e. larger viral log reduction) in patients who happened to be taking ezetimibe (EZE). Hence, the objective of this study is to assess whether the FDA-approved drug (ezetimibe) is useful for the treatment of chronic HCV. The investigators predict that when administered as monotherapy ezetimibe will reduce HCV viremia perhaps allowing for viral clearance and that when included in combination treatment regimens that EZE will increase HCV decline resulting in faster viral clearance (i.e. shorter/cheaper direct-acting antiviral \[DAA\] therapy). To test these hypotheses, the investigators will execute the following aims: (1) Assess the efficacy of EZE monotherapy in chronically HCV infected and predict time to cure; (2) Assess the efficacy of EZE as an adjunct therapy in chronically HCV infected patients undergoing currently approved HCV DAA treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.