Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
NCT00487318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2012-08-21
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.
Conditions
- Chronic Hepatitis C
Interventions
- DRUG
-
standard of care
peginterferon/RBV
- DRUG
-
fluvastatin
Add fluvastatin at 20-40 mg/day to standard of care
Sponsors & Collaborators
-
US Department of Veterans Affairs
collaborator FED -
Bader, Ted, M.D.
lead INDIV
Principal Investigators
-
Ted F Bader, MD · OUHSC and VAMC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2010-10-31
- Completion
- 2010-10-31
Countries
- United States
Study Locations
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