Hepatitis CPhase 2NCT00403533
Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
A Phase 2 study testing 20 mg of atorvastatin daily in people with Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication. Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- 20 mg of atorvastatin daily
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jul 2006
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic HCV.
- Patients who need treatment for their elevated cholesterol:
- Total cholesterol >240 or
- LDL >160 without cardiac risk factors or
- LDL >130 with two cardiac risk factors (hypertension, smoker, family history of heart attach, or HDL <40 for men or <50 for women) or
- LDL >100 with diabetes or known coronary artery disease
Who cannot join
- Impaired mental ability preventing a subject from understanding the protocol or from completing the entire study.
- HCC
- A history of an adverse reaction to any HMG CoA reductase inhibitor.
- Patients who are on HCV treatment, who plan to initiate HCV treatment within 3 months, or who discontinued HCV treatment within the last 3 months.
- Patients whose aminotransferases are > 5 times the upper limit of normal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication.
Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.
Read the detailed description
Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from Massachusetts General Hospital.
The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator.
Each subject who consents will undergo phlebotomy of 10 cc of blood three times. Once prior to the initiation of atorvastatin to measure the patients viral load. In addition, patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects. Therefore patients who enroll in this study will undergo one additional phlebotomy. As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load.
- Conditions
- Hepatitis C
- Being tested
- 20 mg of atorvastatin daily
- Keywords
- Hepatitis C, viral load, antiviral therapy, cholesterol, atorvastatin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg of atorvastatin dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired comparison of pretreatment viral load to post-treatment 12 week viral load
Secondary outcomes (1)
Paired comparison of pretreatment viral load to post-treatment 4 week viral load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startFeb 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Raymond T Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403533
- Sponsor's protocol ID
- 2006-P-000138/1
- Other IDs
- AASLD advanced hepato. grant
- Status last verified
- Nov 2006
- First submitted
- 21 Nov 2006
- Last updated
- 23 Nov 2006
- Results posted
- No
Publications
Ikeda M, Abe K, Yamada M, Dansako H, Naka K, Kato N. Different anti-HCV profiles of statins and their potential for combination therapy with interferon. Hepatology. 2006 Jul;44(1):117-25. doi: 10.1002/hep.21232.
PubMed 16799963Kapadia SB, Chisari FV. Hepatitis C virus RNA replication is regulated by host geranylgeranylation and fatty acids. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2561-6. doi: 10.1073/pnas.0409834102. Epub 2005 Feb 7.
PubMed 15699349Aizaki H, Lee KJ, Sung VM, Ishiko H, Lai MM. Characterization of the hepatitis C virus RNA replication complex associated with lipid rafts. Virology. 2004 Jul 1;324(2):450-61. doi: 10.1016/j.virol.2004.03.034.
PubMed 15207630
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT00403533
- Acronym / sponsor ID
- 2006-P-000138/1
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, viral load, antiviral therapy, cholesterol, atorvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Jul 2006
- First posted
- 23 Nov 2006 (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.
We hypothesize that atorvastatin will decrease HCV viral load in patients taking the medication.
Cholesterol is needed for HCV virion production. Cell culture studies have shown that atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.
Detailed description
Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from Massachusetts General Hospital.
The study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator.
Each subject who consents will undergo phlebotomy of 10 cc of blood three times. Once prior to the initiation of atorvastatin to measure the patients viral load. In addition, patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. The week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects. Therefore patients who enroll in this study will undergo one additional phlebotomy. As part of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV viral load.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with chronic HCV.
- Patients who need treatment for their elevated cholesterol:
Key exclusion criteria (5 listed)
- Impaired mental ability preventing a subject from understanding the protocol or from completing the entire study.
- HCC
- A history of an adverse reaction to any HMG CoA reductase inhibitor.
- Patients who are on HCV treatment, who plan to initiate HCV treatment within 3 months, or who discontinued HCV treatment within the last 3 months.
- Patients whose aminotransferases are > 5 times the upper limit of normal.
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 |
|---|---|---|
| 20 mg of atorvastatin daily | Drug | – |
Primary outcome
Paired comparison of pretreatment viral load to post-treatment 12 week viral load
1 secondary outcome
Paired comparison of pretreatment viral load to post-treatment 4 week viral load
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 23 Nov 2006.
- Background: PubMed 16799963Ikeda M, Abe K, Yamada M, Dansako H, Naka K, Kato N. Different anti-HCV profiles of statins and their potential for combination therapy with interferon. Hepatology. 2006 Jul;44(1):117-25. doi: 10.1002/hep.21232.
- Background: PubMed 15699349Kapadia SB, Chisari FV. Hepatitis C virus RNA replication is regulated by host geranylgeranylation and fatty acids. Proc Natl Acad Sci U S A. 2005 Feb 15;102(7):2561-6. doi: 10.1073/pnas.0409834102. Epub 2005 Feb 7.
- Background: PubMed 15207630Aizaki H, Lee KJ, Sung VM, Ishiko H, Lai MM. Characterization of the hepatitis C virus RNA replication complex associated with lipid rafts. Virology. 2004 Jul 1;324(2):450-61. doi: 10.1016/j.virol.2004.03.034.
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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.
Raymond T Chung, MD principal investigator
Massachusetts General Hospital
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 20 mg of atorvastatin daily in people with Hepatitis C, run by Massachusetts General Hospital 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 6 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: finished, as of the sponsor's last update on 23 Nov 2006. 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?
Paired comparison of pretreatment viral load to post-treatment 12 week viral load. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403533, which also lists 3 linked publications.
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 23 Nov 2006.