HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

Bader, Ted, M.D.

Status and phase: Terminated; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: statin

Study type: Interventional

Identifiers

NCT01377909

Bader 15859

Details and patient eligibility

About

Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.

Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening

Exclusion criteria

• decompensated liver disease
• severe cardiac disease (ejection fraction < 20% or uncontrolled angina)
• unexplained muscle pain at time of screening
• pregnancy
• renal insufficiency (creatine clearance < 50 ml/min)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

statin

Experimental group

Treatment:

Drug: statin