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Arm 1 Plus statin for Chronic Hepatitis C
Phase 2
Waitlist Available
Led By Ted F Bader, MD
Research Sponsored by Bader, Ted, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Chronic Hepatitis C
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 Plus statinExperimental Treatment1 Intervention
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
Group II: 2Active Control1 Intervention
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluvastatin
FDA approved
Find a Location
Who is running the clinical trial?
Bader, Ted, M.D.Lead Sponsor
5 Previous Clinical Trials
118 Total Patients Enrolled
US Department of Veterans AffairsFED
873 Previous Clinical Trials
497,808 Total Patients Enrolled
Ted F Bader, MDPrincipal InvestigatorOUHSC and VAMC
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