A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sustained Viral response
Study Overview
Brief Summary
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Not previously treated.
- •Off alcohol and marijuana for 6 months
- •HCV RNA positive
Exclusion Criteria
- •HIV positive
- •Advanced liver disease
- •Advanced cardiopulmonary disease
- •Chronic renal failure
Arms & Interventions
Arm 1 Plus statin
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
Intervention: fluvastatin (Drug)
2
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
Intervention: standard of care (Drug)
Outcomes
Primary Outcomes
Sustained Viral response
Time Frame: 72 weeks
Secondary Outcomes
- Viral load at 4, 12 and 24 weeks(24 weeks)
Investigators
Ted Bader, MD
Director of Liver Diseases, VA Medical Center
Bader, Ted, M.D.