Trials / Completed
CompletedNCT00487318
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Bader, Ted, M.D. · Individual
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | standard of care | peginterferon/RBV |
| DRUG | fluvastatin | Add fluvastatin at 20-40 mg/day to standard of care |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2007-06-18
- Last updated
- 2012-08-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00487318. Inclusion in this directory is not an endorsement.