Back to resultsA 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
Primary Purpose
Hepatitis C, Hepatitis C Virus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fluvastatin
Peginterferon alfa2a
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring genotype 1 hepatitis C, hepatitis C, HCV, liver
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group
Arm Description
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).
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00814606
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
no one ever enrolled
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis C Virus
Keywords
genotype 1 hepatitis C, hepatitis C, HCV, liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
Intervention Description
Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa2a
Other Intervention Name(s)
Pegasys
Intervention Description
180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9)
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Gautham Reddy, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
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
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