HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

NCT01377909 | Terminated Phase 1

• 1 other identifier: Bader 15859
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis C

Keywords

chronic hepatitis C, interferon

Outcome Measures

Primary Outcomes (1)

• Improvement in peginterferon response as measured by change in HCV RNA levels

  The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically.

  48 weeks

Secondary Outcomes (1)

• The response of interferon stimulated genes

  48 weeks

Study Arms (1)

statin

EXPERIMENTAL

Drug: statin

Interventions

statin DRUG

daily statin orally for 48 weeks

statin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bader, Ted, M.D.: lead

Study Sites (1)

Veterans Administration Medical Center (VAMC)

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Ted Bader, M.D.

  VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Diseases, Professor, Department of Medicine, Section of Gastroenterology

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

US (1)