Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

Bader, Ted, M.D.

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: fluvastatin; Drug: standard of care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00487318

13358

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm 1 Plus statin

Experimental group

Description:

The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.

Treatment:

Drug: fluvastatin

2

Active Comparator group

Description:

Administration of the standard of care for hepatitis C of peginterferon and ribavirin.

Treatment:

Drug: standard of care