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Trial record 5 of 6 for:    "Hepatitis" | "Ezetimibe"

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

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ClinicalTrials.gov Identifier: NCT02126137
Recruitment Status : Unknown
Verified November 2015 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : April 29, 2014
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Ezetimibe Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Effect of Ezetimibe in Patients With Chronic Hepatitis C Infection
Study Start Date : October 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

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



Primary Outcome Measures :
  1. HCV plasma viral load [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. HCV biliary viral load [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126137


Contacts
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Contact: Pilar Labbé, RN +56223543820 pililabbe@gmail.com

Locations
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Chile
Department of Gastroenterology, Pontificia Universidad Católica de Chile Recruiting
Santiago, Metropolitan, Chile, 8330024
Contact: Pilar Labbé, RN    +56223543820    pililabbe@gmail.com   
Principal Investigator: Alejandro Soza, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Alejandro Soza, MD Pontificia Universidad Catolica de Chile

Additional Information:
Publications:
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02126137     History of Changes
Other Study ID Numbers: 12-199
1130357 ( Other Grant/Funding Number: FONDECYT )
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015
Keywords provided by Pontificia Universidad Catolica de Chile:
HCV
Ezetimibe
Cholesterol
Host
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Ezetimibe
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents