HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
This study is currently recruiting participants.
Verified August 2012 by Bader, Ted, M.D.
Sponsor:
Bader, Ted, M.D.
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D.
ClinicalTrials.gov Identifier:
NCT01377909
First received: June 20, 2011
Last updated: August 20, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: statin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders |
Resource links provided by NLM:
Further study details as provided by Bader, Ted, M.D.:
Primary Outcome Measures:
- Improvement in peginterferon response as measured by change in HCV RNA levels [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- The response of interferon stimulated genes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: statin |
Drug: statin
daily statin orally for 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377909
Contacts
| Contact: Paula J Allen, MA | 405-456-3982 | paula.allen2@va.gov |
| Contact: Hailey B Hill, AAS,ASCR | 405-456-3982 | hailey.hill@va.gov |
Locations
| United States, Oklahoma | |
| Veterans Administration Medical Center (VAMC) | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Paula J Allen, MA 405-456-3982 paula.allen2@VA.gov | |
| Contact: Hailey B Hill, AAS,ASCR 405-456-3982 hailey.hill@va.gov | |
| Principal Investigator: Ted Bader, M.D. | |
Sponsors and Collaborators
Bader, Ted, M.D.
Investigators
| Principal Investigator: | Ted Bader, M.D. | Department of Veterans Affairs |
More Information
No publications provided
| Responsible Party: | Ted Bader, MD, Director of Liver Diseases, Professor, Department of Medicine, Section of Gastroenterology, Bader, Ted, M.D. |
| ClinicalTrials.gov Identifier: | NCT01377909 History of Changes |
| Other Study ID Numbers: | Bader 15859 |
| Study First Received: | June 20, 2011 |
| Last Updated: | August 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bader, Ted, M.D.:
|
chronic hepatitis C, interferon |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons |
Peginterferon alfa-2b Hydroxymethylglutaryl-CoA Reductase Inhibitors Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 18, 2013