Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection in Liver Transplant Candidates (EZE-2)

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

NPC1L1 is a key transporter in the enterohepatic cycle of cholesterol. Initial in vitro and in vivo data show that blocking this receptor with ezetimibe results in delaying infection in these models. The investigators hypothesize that HCV has an enterohepatic cycle, being secreted in bile and reabsorbed either in the canalicular membrane or in the intestine by association with NPC1L1, following a path similar to the cycle of cholesterol in humans. To prove this hypothesis the investigators propose to assess the effect of ezetimibe treatment in HCV infected individuals undergoing liver transplantation to avoid or delay HCV infection. For this purpose, the investigators propose to administrate ezetimibe 10 mg/d for 12 weeks to 12 patients with chronic hepatitis C infection listed for a liver transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Treatments: Ezetimibe

Criteria

Inclusion Criteria:

• Chronic hepatitis C defined as detectable HCV RNA for more than 6 months.

• Age > 18 years old.

• No current HCV antiviral treatment.

• No medications for dyslipidemia in the preceding 2 months.

• Listed in the national waiting list for liver transplant with an estimated time to transplantation of 3 months or less, either for complications of cirrhosis or for hepatocellular carcinoma.

• No abdominal surgery that could alter biliary or intestinal anatomy.

• HCV RNA level > 10.000 IU/mL.

• No evidence of sitosterolemia.

• Negative pregnancy test in urine (for females).

• Signed informed consent document.

Exclusion Criteria:

• Hepatitis B or HIV co-infection.