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Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

NCT ID: NCT00487318

Last Updated: 2012-08-21

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 Plus statin

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

Group Type EXPERIMENTAL

fluvastatin

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

standard of care

Intervention Type DRUG

peginterferon/RBV

Interventions

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standard of care

peginterferon/RBV

Intervention Type DRUG

fluvastatin

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

Intervention Type DRUG

Other Intervention Names

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Lescol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

Bader, Ted, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Ted Bader, MD

Director of Liver Diseases, VA Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ted F Bader, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC and VAMC

Locations

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Veterans Administration Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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13358

Identifier Type: -

Identifier Source: org_study_id