Pilot Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection (EZE-1)

November 3, 2015 updated by: Pontificia Universidad Catolica de Chile

A Pilot Study of the Effect of Ezetimibe in Patients With Chronic Hepatitis C Infection

Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and 80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause for liver transplantation in Chile. Even though treatments are evolving with new direct antiviral agents (DAAs) that are increasing response rates, there are several issues with these new approaches, including increased toxicity, need for using interferon and ribavirin, complex algorithms of treatment, high cost, limited effectivity in certain groups (liver transplant patients) and drug interactions. Treatments targeted at host factors required for the viral cycle are becoming increasingly explored as an alternative or complement to DAAs. It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an approved and generally safe drug used for the management of hypercholesterolemia. Our hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20 mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV RNA and core antigen in plasma, bile and feces.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitan
      • Santiago, Metropolitan, Chile, 8330024
        • Recruiting
        • Department of Gastroenterology, Pontificia Universidad Catolica de Chile
        • Contact:
        • Principal Investigator:
          • Alejandro Soza, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Chronic hepatitis C defined as detectable HCV RNA for more than 6 months.
  • Age > 18 years old.
  • Compensated liver disease (bilirubin < 3mg/dL, unless having Gilbert´s syndrome, albumin > 3 g/dL, INR < 2, no hepatic encephalopathy, no ascites or recent -1 month- history of variceal bleeding).
  • HCV RNA level > 10.000 IU/mL.
  • Signed informed consent document.

Exclusion criteria:

  • History of cholecystectomy or known gallstones.
  • Current HCV antiviral treatment.
  • Medications for dyslipidemia in the preceding 2 months.
  • Abdominal surgery that could alter biliary or intestinal anatomy.
  • Evidence of sitosterolemia.
  • Negative pregnancy test in urine (for females).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ezetimibe
Ezetimibe administered by mouth 10 mg BID for 12 weeks
Drug: Ezetimibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HCV plasma viral load
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HCV biliary viral load
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

April 27, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-199
  • 1130357 (Other Grant/Funding Number: FONDECYT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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