Chronic Hepatitis CPhase 2NCT00487318
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
A Phase 2 study testing fluvastatin in people with Chronic Hepatitis C, run by Bader, Ted, M.D. at 1 site in United States.
Trial summary
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- fluvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not previously treated.
- Off alcohol and marijuana for 6 months
- HCV RNA positive
Who cannot join
- HIV positive
- Advanced liver disease
- Advanced cardiopulmonary disease
- Chronic renal failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Administration Medical Center
Oklahoma City, Oklahoma, 73104
About this study
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.
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
- Conditions
- Chronic Hepatitis C
- Being tested
- standard of care, fluvastatin
- Keywords
- fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careDrug
peginterferon/RBV
fluvastatinDrug
Also called Lescol
Add fluvastatin at 20-40 mg/day to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Plus statin | Experimental | The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin. Receives: Drug: fluvastatin |
| 2 | Active comparator | Administration of the standard of care for hepatitis C of peginterferon and ribavirin. Receives: Drug: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral response
Measured: 72 weeks
Secondary outcomes (1)
Viral load at 4, 12 and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bader, Ted, M.D.
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Ted Bader, MD, Bader, Ted, M.D.
- Investigators
- Ted F Bader, MD, Principal investigator, OUHSC and VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487318
- Sponsor's protocol ID
- 13358
- Status last verified
- Aug 2012
- First submitted
- 15 Jun 2007
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00487318
- Acronym / sponsor ID
- 13358
- Conditions
- Chronic Hepatitis C
- Keywords
- fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bader, Ted, M.D.
- Collaborators
- US Department of Veterans Affairs
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 Jun 2007 (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.
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Plus statin | Experimental | Drug: fluvastatinThe addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin. |
| 2 | Active comparator | Drug: standard of careAdministration of the standard of care for hepatitis C of peginterferon and ribavirin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not previously treated.
- Off alcohol and marijuana for 6 months
- HCV RNA positive
Key exclusion criteria (4 listed)
- HIV positive
- Advanced liver disease
- Advanced cardiopulmonary disease
- Chronic renal failure
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 |
|---|---|---|
| standard of carepeginterferon/RBV | Drug | 2 |
| fluvastatinAlso: LescolAdd fluvastatin at 20-40 mg/day to standard of care | Drug | Arm 1 Plus statin |
Primary outcome
Sustained Viral response
Time frame: 72 weeks
1 secondary outcome
Viral load at 4, 12 and 24 weeks
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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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.
Ted F Bader, MD principal investigator
OUHSC and VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluvastatin in people with Chronic Hepatitis C, run by Bader, Ted, M.D. at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sustained Viral response (time frame: 72 weeks). 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 21 Aug 2012.