A Randomized, Controlled Trial of Fluvastatin Added to Pegylated Interferon and Ribavirin (PI+R) Versus PI+R Alone for Treatment of Chronic Hepatitis C Not Previously Treated
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...
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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 Investigator Information
Lead Investigator: Bader, Ted, M.D. Other
Overall Clinical Trial Officials and Contacts
Overall Contact: Joe Cardello 405-270-0501 jcardello1@cox.net
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00487318
