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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

This study has been withdrawn prior to enrollment.
(no one ever enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814606
First Posted: December 25, 2008
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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
Hepatitis C Hepatitis C Virus Drug: Fluvastatin Drug: Peginterferon alfa2a Drug: ribavirin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Efficacy of adding fluvastatin to pegylated interferon alfa-2a and ribavirin in patients infected with genotype 1 HCV who are previous partial responders to standard treatment. [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Safety of adding fluvastatin to pegylated interferon alfa-2a and ribavirin in patients infected with genotype 1 HCV who are previous partial responders to standard treatment. [ Time Frame: 18 months ]

Enrollment: 0
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Group
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).
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)
Other Name: Pegasys
Drug: ribavirin
1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
Other Name: Copegus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any ethnicity age 18 - 65 years with genotype 1 HCV
  • Previous partial responder to attempts at HCV therapy with PEG/RBV (at least 1 log drop but less than 2 log drop in HCV RNA at 12 weeks)
  • Previous history or serum HCV-RNA PCR quantifiable by Roche Amplicore HCV Test
  • A liver biopsy within 3 years of study enrollment consistent with HCV disease.
  • Compensated liver disease, Child-Pugh Class ≤ 6
  • Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug
  • All patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. Exceptions may include partner/participant is surgically sterile.
  • Willingness to comply with study procedures and provide written informed consent

Exclusion Criteria:

  • AST or ALT > 10 ULN
  • Any investigational drug ≤ 12 weeks prior to the first of study drug
  • Prior intolerance to statin medications
  • Previous serious side effects to IFN or RBV (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to IFN/RBV requiring treatment discontinuation)
  • Any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. Exception: Patients who have taken or are expected to require such treatment for herpetic lesions
  • Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc-IgM Ab ,or anti-HIV Ab
  • Serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease
  • History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis)
  • Women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00814606


Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: K Gautham Reddy, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00814606     History of Changes
Other Study ID Numbers: 16336A
First Submitted: December 23, 2008
First Posted: December 25, 2008
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by University of Chicago:
genotype 1 hepatitis C
hepatitis C
HCV
liver

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Fluvastatin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors