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Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
standard of care
fluvastatin
Sponsored by
Bader, Ted, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Veterans Administration Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 Plus statin

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sustained Viral response

Secondary Outcome Measures

Viral load at 4, 12 and 24 weeks

Full Information

First Posted
June 15, 2007
Last Updated
August 20, 2012
Sponsor
Bader, Ted, M.D.
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00487318
Brief Title
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bader, Ted, M.D.
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Plus statin
Arm Type
Experimental
Arm Description
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
Intervention Type
Drug
Intervention Name(s)
standard of care
Intervention Description
peginterferon/RBV
Intervention Type
Drug
Intervention Name(s)
fluvastatin
Other Intervention Name(s)
Lescol
Intervention Description
Add fluvastatin at 20-40 mg/day to standard of care
Primary Outcome Measure Information:
Title
Sustained Viral response
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Viral load at 4, 12 and 24 weeks
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted F Bader, MD
Organizational Affiliation
OUHSC and VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Administration Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

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