Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
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ClinicalTrials.gov Identifier: NCT00487318 |
Recruitment Status :
Completed
First Posted : June 18, 2007
Last Update Posted : August 21, 2012
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C | Drug: standard of care Drug: fluvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 Plus statin
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
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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.
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Drug: standard of care
peginterferon/RBV |
- Sustained Viral response [ Time Frame: 72 weeks ]
- Viral load at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487318
United States, Oklahoma | |
Veterans Administration Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 |
Principal Investigator: | Ted F Bader, MD | OUHSC and VAMC |
Responsible Party: | Ted Bader, MD, Director of Liver Diseases, VA Medical Center, Bader, Ted, M.D. |
ClinicalTrials.gov Identifier: | NCT00487318 |
Other Study ID Numbers: |
13358 |
First Posted: | June 18, 2007 Key Record Dates |
Last Update Posted: | August 21, 2012 |
Last Verified: | August 2012 |
fluvastatin hepatitis C chronic hepatitis C not previously treated with pegylated interferon and ribavirin |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections |