Chronic Hepatitis CPhase 1NCT01377909
HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
A Phase 1 study testing statin in people with Chronic Hepatitis C, run by Bader, Ted, M.D. at 1 site in United States.
Trial summary
Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV. Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible. 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?
- statin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2013
- Phase
- Phase 1
- 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
- Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening
Who cannot join
- decompensated liver disease
- severe cardiac disease (ejection fraction < 20% or uncontrolled angina)
- unexplained muscle pain at time of screening
- pregnancy
- renal insufficiency (creatine clearance < 50 ml/min)
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Administration Medical Center (VAMC)
Oklahoma City, Oklahoma, 73104
About this study
Official title: An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders
Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.
Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.
- Conditions
- Chronic Hepatitis C
- Being tested
- statin
- Keywords
- chronic hepatitis C, interferon
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statinDrug
daily statin orally for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| statin | Experimental | Not described Receives: Drug: statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in peginterferon response as measured by change in HCV RNA levels
The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically.
Measured: 48 weeks
Secondary outcomes (1)
The response of interferon stimulated genes
The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013
Why it stopped: Principal Investigator retiring
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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bader, Ted, M.D.
- Responsible party
- Principal investigator, Ted Bader, MD, Bader, Ted, M.D.
- Investigators
- Ted Bader, M.D., Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377909
- Sponsor's protocol ID
- Bader 15859
- Status last verified
- Aug 2013
- First submitted
- 20 Jun 2011
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders
- ClinicalTrials.gov ID
- NCT01377909
- Acronym / sponsor ID
- Bader 15859
- Conditions
- Chronic Hepatitis C
- Keywords
- chronic hepatitis C, interferon
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator retiring
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bader, Ted, M.D.
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Jun 2011 (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.
Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.
Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| statin | Experimental | Drug: statin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening
Key exclusion criteria (5 listed)
- decompensated liver disease
- severe cardiac disease (ejection fraction < 20% or uncontrolled angina)
- unexplained muscle pain at time of screening
- pregnancy
- renal insufficiency (creatine clearance < 50 ml/min)
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 |
|---|---|---|
| statindaily statin orally for 48 weeks | Drug | statin |
Primary outcome
Improvement in peginterferon response as measured by change in HCV RNA levels
Time frame: 48 weeks
The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically.
1 secondary outcome
The response of interferon stimulated genes
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: Principal Investigator retiring). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 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.
Ted Bader, M.D. principal investigator
VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing statin 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 22 Aug 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Principal Investigator retiring). Results are not available in the source record.
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?
Improvement in peginterferon response as measured by change in HCV RNA levels (time frame: 48 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 22 Aug 2013.