Hepatitis CPhase 2NCT00814606
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
A Phase 2 study testing Fluvastatin, Peginterferon alfa2a and ribavirin in people with Hepatitis C and Hepatitis C Virus, run by University of Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Hepatitis C Virus
- What is being tested?
- Fluvastatin, Peginterferon alfa2a and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.
- Conditions
- Hepatitis C, Hepatitis C Virus
- Being tested
- Fluvastatin, Peginterferon alfa2a, ribavirin
- Keywords
- genotype 1 hepatitis C, hepatitis C, HCV, liver
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily
Peginterferon alfa2aDrug
Also called Pegasys
180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9)
ribavirinDrug
Also called Copegus
1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Fluvastatin; Drug: Peginterferon alfa2a; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startFeb 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: no one ever enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K Gautham Reddy, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814606
- Sponsor's protocol ID
- 16336A
- Status last verified
- Jun 2013
- First submitted
- 23 Dec 2008
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00814606
- Acronym / sponsor ID
- 16336A
- Conditions
- Hepatitis C, Hepatitis C Virus
- Keywords
- genotype 1 hepatitis C, hepatitis C, HCV, liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no one ever enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Drug: Fluvastatin, Drug: Peginterferon alfa2a, Drug: ribavirin8 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluvastatinWeek 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily | Drug | Single Group |
| Peginterferon alfa2aAlso: Pegasys180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9) | Drug | Single Group |
| ribavirinAlso: Copegus1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9) | Drug | Single Group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K Gautham Reddy, MD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluvastatin, Peginterferon alfa2a and ribavirin in people with Hepatitis C and Hepatitis C Virus, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.