Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

This study has been completed.

Sponsor:

Collaborator:

VA Office of Research and Development

Information provided by (Responsible Party):

Ted Bader, MD, Bader, Ted, M.D.

ClinicalTrials.gov Identifier:

NCT00487318

First received: June 15, 2007

Last updated: August 20, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: standard of care Drug: fluvastatin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Statins

Drug Information available for: Interferon Ribavirin Fluvastatin Fluvastatin sodium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Bader, Ted, M.D.:

Primary Outcome Measures:

Sustained Viral response [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Viral load at 4, 12 and 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	40
Study Start Date:	June 2007
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Plus statin The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.	Drug: fluvastatin Add fluvastatin at 20-40 mg/day to standard of care Other Name: Lescol
Active Comparator: 2 Administration of the standard of care for hepatitis C of peginterferon and ribavirin.	Drug: standard of care peginterferon/RBV

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487318

Locations


United States, Oklahoma
Veterans Administration Medical Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

Bader, Ted, M.D.

VA Office of Research and Development

Investigators


Principal Investigator:	Ted F Bader, MD	OUHSC and VAMC

More Information


Responsible Party:	Ted Bader, MD, Director of Liver Diseases, VA Medical Center, Bader, Ted, M.D.
ClinicalTrials.gov Identifier:	NCT00487318 History of Changes
Other Study ID Numbers:	13358
Study First Received:	June 15, 2007
Last Updated:	August 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bader, Ted, M.D.:


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

Additional relevant MeSH terms:


Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons	Ribavirin Rosuvastatin Calcium Fluvastatin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Enzyme Inhibitors Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 29, 2016

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