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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00487318

Enrollment

Registered

2007-06-18

Start date

2007-06-30

Completion date

2010-10-31

Last updated

2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin

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.

Interventions

DRUGstandard of care

peginterferon/RBV

DRUGfluvastatin

Add fluvastatin at 20-40 mg/day to standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sustained Viral response	72 weeks

Secondary

Measure	Time frame
Viral load at 4, 12 and 24 weeks	24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026