Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
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.
Investigators
Principal Investigator: Ted F Bader, MD OUHSC and VAMC
  More Information

No publications provided

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, 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
Ribavirin
Fluvastatin
Rosuvastatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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 July 22, 2014