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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00814606 |
This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.
Condition | Intervention | Phase |
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Hepatitis C Hepatitis C Virus |
Drug: Fluvastatin Drug: Peginterferon alfa2a Drug: ribavirin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C |
Estimated Enrollment: | 5 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Group: Experimental
8 weeks period of escalating doses of fluvastatin to a goal dose of 80mg daily, then patients will start treatment of HCV at week 9 with the usual standard of care protocol for medication dose, office visits and laboratories. Peginterferon alfa2a 180 mcg/ml SQ injection once a week for 48 weeks and ribavirin 1000-1200 mg daily orally in two divided doses for 48 weeks. Patients weighing < 75 kg will receive 1000mg per day (400mg in the morning and 600mg in the evening). Patients weighing ≥ 75 kg will receive 1200 mg per day (600mg in the morning and 600 mg in the evening).
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Drug: Fluvastatin
Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily
Drug: Peginterferon alfa2a
180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9)
Drug: ribavirin
1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katie Wherity, RN | 773-702-4477 | kwherity@medicine.bsd.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Principal Investigator: K Gautham Reddy, MD |
Principal Investigator: | K Gautham Reddy, MD | University of Chicago |
Responsible Party: | The University of Chicago ( K Gautham Reddy, MD ) |
Study ID Numbers: | 16336A |
Study First Received: | December 23, 2008 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00814606 |
Health Authority: | United States: Institutional Review Board |
genotype 1 hepatitis C hepatitis C HCV liver |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Interferons |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Fluvastatin |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Therapeutic Uses |
Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Pharmacologic Actions |