NCT02126137

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

April 27, 2014

Last Update Submit

November 3, 2015

Conditions

Chronic Hepatitis C

Keywords

HCVEzetimibeCholesterolHost

Outcome Measures

Primary Outcomes (1)

  • HCV plasma viral load

    12 weeks

Secondary Outcomes (1)

  • HCV biliary viral load

    12 weeks

Study Arms (1)

Ezetimibe

EXPERIMENTAL

Ezetimibe administered by mouth 10 mg BID for 12 weeks

Drug: Ezetimibe

Interventions

EzetimibeDRUG
Ezetimibe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Pontificia Universidad Católica de Chile

Santiago, Metropolitan, 8330024, Chile

RECRUITING

Related Publications (1)

  • Sainz B Jr, Barretto N, Martin DN, Hiraga N, Imamura M, Hussain S, Marsh KA, Yu X, Chayama K, Alrefai WA, Uprichard SL. Identification of the Niemann-Pick C1-like 1 cholesterol absorption receptor as a new hepatitis C virus entry factor. Nat Med. 2012 Jan 8;18(2):281-5. doi: 10.1038/nm.2581.

    PMID: 22231557BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alejandro Soza, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pilar Labbé, RN

CONTACT

+56223543820pililabbe@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2014

First Posted

April 29, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

CL(1)