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...
Date First Received: June 15, 2007
Last Updated: July 27, 2008
Verified by: Bader, Ted, M.D., July 2008
Clinical Trial Phase: Phase 2 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 170
Brief Summary
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: January 2011
Intervention(s) in this Clinical Trial
- Drug: standard of care
- peginterferon/RBV
- Drug: fluvastatin
- Add fluvastatin at 20-40 mg/day to standard of care
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- fluvastatin added to standard of care
- Active Comparator: 2
- standard of care peginterferon and ribavirin
Outcome Measures for this Clinical Trial
Primary Measures
- Sustained Viral response
- Time Frame: 72 weeks
Safety Issue?: Yes
- Time Frame: 72 weeks
Secondary Measures
- Viral load at 4, 12 and 24 weeks
- Time Frame: 24 weeks
Safety Issue?: Yes
- Time Frame: 24 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bader, Ted, M.D.
Overall Clinical Trial Officials and Contacts
Overall Contact: Joe Cardello 405-270-0501 jcardello1@cox.net
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487318
Study ID Number: 13358
ClinicalTrials.gov Identifier: NCT00487318
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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