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HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

NCT ID: NCT01377909

Last Updated: 2013-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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chronic hepatitis C, interferon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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statin

Group Type EXPERIMENTAL

statin

Intervention Type DRUG

daily statin orally for 48 weeks

Interventions

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statin

daily statin orally for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bader, Ted, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Ted Bader, MD

Director of Liver Diseases, Professor, Department of Medicine, Section of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ted Bader, M.D.

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center

Locations

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Veterans Administration Medical Center (VAMC)

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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Bader 15859

Identifier Type: -

Identifier Source: org_study_id