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NCT02971033 · ClinicalTrials.gov registry record · Phase 2
Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT02971033: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT02971033 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02971033, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers to viral resistance and strategies to shorten the current treatment duration, the goal is to develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of those inhibitors for treating HCV infection. The investigators recently discovered that a major cholesterol uptake receptor is required for HCV entry into hepatocytes and that there is already an FDA-approved drug that inhibits cholesterol uptake by this receptor. Importantly the same drug also potently blocks HCV entry in human liver cells both in cell culture and in a small animal model. Further, looking back at people who were previously treated for HCV infection, the investigators found treatment response to be better (i.e. larger viral log reduction) in patients who happened to be taking ezetimibe (EZE). Hence, the objective of this study is to assess whether the FDA-approved drug (ezetimibe) is useful for the treatment of chronic HCV. The investigators predict that when administered as monotherapy ezetimibe will reduce HCV viremia perhaps allowing for viral clearance and that when included in combination treatment regimens that EZE will increase HCV decline resulting in faster viral clearance (i.e. shorter/cheaper direct-acting antiviral \[DAA\] therapy). To test these hypotheses, the investigators will execute the following aims: (1) Assess the efficacy of EZE monotherapy in chronically HCV infected and predict time to cure; (2) Assess the efficacy of EZE as an adjunct therapy in chronically HCV infected patients undergoing currently approved HCV DAA treatment.
Interventions
- DRUG Placebo
- DRUG 20mg ezetimibe
- DRUG 40mg ezetimibe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02971033
The ClinicalTrials.gov registry entry for NCT02971033 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02971033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02971033 about?
NCT02971033 is a clinical study titled "Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C". To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers to viral resistance and strategies to shorten the current treatment duration, the goal is to develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of those inhibitors for...
What is the current status of trial NCT02971033?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-04-16. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT02971033?
The interventions under investigation include: Placebo (DRUG), 20mg ezetimibe (DRUG), 40mg ezetimibe (DRUG).
Who is sponsoring clinical trial NCT02971033?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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