Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02971033|
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: 20mg ezetimibe Drug: Placebo Drug: 40mg ezetimibe||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C|
|Actual Study Start Date :||April 16, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Placebo Comparator: placebo
Participants assigned to this intervention will receive placebo every day for 12 weeks
Experimental: 20mg/day ezetimibe
Drug: 20mg ezetimibe
Participants assigned to this intervention will receive 20mg per day of ezetimibe for 12 weeks.
Other Name: 20mg Zetia
Experimental: 40mg/day exetimibe
Drug: 40mg ezetimibe
Participants assigned to this intervention will receive 40mg per day of ezetimibe for 12 weeks.
Other Name: 40mg Zetia
- Change in viral decline [ Time Frame: 12 weeks ]Participants will have their HCV-RNA measured in copies per milliliter at baseline and 12 weeks. HCV-RNA in copies per milliliter ranges from 0 to infinity, with higher levels indicating HCV positivity. The change in copies per milliliter will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day).
- Change in alanine aminotransferase (ALT) [ Time Frame: 12 weeks ]Participants will have their ALT levels measured in units per liter (U/L) at baseline and 12 weeks. ALT ranges from 0 to infinity with higher levels of ALT indicating hepatocyte death. The change in ALT levels will be compared among the three intervention groups (i.e., placebo or control cohort, those assigned to 20mg ezetimibe per day, and 40mg ezetimibe per day).
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): NCT02971033
|Contact: Susan L Uprichard, PhD||(708) 202-8387 ext 25848||Susan.Uprichard@va.gov|
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL||Recruiting|
|Hines, Illinois, United States, 60141-5000|
|Contact: Susan L Uprichard, PhD 708-202-8387 ext 25848 Susan.Uprichard@va.gov|
|Principal Investigator: Susan L. Uprichard, PhD|
|Principal Investigator:||Susan L. Uprichard, PhD||Edward Hines Jr. VA Hospital, Hines, IL|