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

Chronic Hepatitis C Clinical Trial

— EZE-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02126137
• Other study ID #: 12-199
• Secondary ID: 1130357
• Status: Recruiting
• Phase: Phase 1
• First received: April 27, 2014
• Last updated: November 3, 2015
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: Pilar Labbé, RN
• Phone: +56223543820
• Email: pililabbe[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de ChileChile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ezetimibe

Locations

Country	Name	City	State
Chile	Department of Gastroenterology, Pontificia Universidad Católica de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV plasma viral load		12 weeks	No
Secondary	HCV biliary viral load		12 weeks	No

External Links

•   Centro de Investigación Clínica UC (CICUC)
•   Information related to hepatitis C / Información de hepatitis por virus C (Spanish)