Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
This study has been completed.
Sponsor:
Bader, Ted, M.D.
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
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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:
Drug Information available for:
Ribavirin
Fluvastatin
Fluvastatin sodium
Rosuvastatin calcium
Rosuvastatin
Hepatitis A Vaccines
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 |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00487318
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 C Hepatitis C, Chronic Hepatitis, Chronic Digestive System Diseases Enterovirus Infections Flaviviridae Infections Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases Fluvastatin |
Ribavirin Rosuvastatin Anti-Infective Agents Anticholesteremic Agents Antimetabolites Antiviral Agents Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015