Chronic Hepatitis CNCT00659256
Hepatitis C Treatment and Atherosclerosis
An observational study of Chronic Hepatitis C and Atherosclerosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will examine the effects of treatment for hepatitis C on atherosclerosis, or hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can cause permanent damage to that organ. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Hepatitis C, Atherosclerosis
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2008to 24 Mar 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 30 years, male or female
- Written informed consent
- All ethnicities
- Viral hepatitis status:
- Cases:
- History of chronic hepatitis C defined by past positivity for serum HCV-RNA, HCV antibody and elevated serum alanine or aspartate aminotransferase levels for at least 6 months before start of treatment
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- Genotype 1, 2 or 3
- Absence of detectable serum HCV-RNA by PCR on screening visit and on a previous test, at least 3 months apart. Both tests have to be performed at least 24 weeks after cessation of therapy
- Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks
- At least 12 months after end of interferon treatment
- Normal liver enzymes on screening visit
- Genotype 1 controls:
- Detectable serum HCV-RNA on screening visit
- Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks
- At least 12 months after end of interferon treatment
- Age (difference less than or equal to 3 years), sex and race-matched with genotype 1 cases
- Genotype 2 and 3 controls:
- Detectable serum HCV-RNA on screening visit
- If previously treated with interferon alfa (standard or pegylated) - at least 12 months elapsed from the end of treatment
- Age (difference less than or equal to 3 years), sex, race and genotype-matched with genotype 2 and 3 cases
Who cannot join
- Pregnancy or lactation
- History of clinical atherosclerotic disease manifest as:
- Ischemic cerebrovascular accident (CVA), transient ischemic accident (TIA) or radiological evidence of stroke.
- Proven coronary artery disease history of myocardial infarction, need for coronary angioplasty or coronary artery bypass graft, anginal syndrome with confirmatory stress test or cardiac imaging.
- Symptomatic peripheral vascular disease, history of angioplasty or surgical bypass.
- History of carotid artery surgery or angioplasty
Show all 17Show fewer
- Patients with overt atherosclerotic disease can be included if the first manifestation of that disease appeared at least 3 years after cessation of interferon treatment. Control patients who were never treated in the past will not be included if there is an overt manifestation of atherosclerosis.
- Diabetes mellitus unless fasting blood sugar can be maintained within normal limits and HBA1C less than 7 without the need for pharmacologic intervention
- Hypertension unless blood pressures can be maintained for greater than 6 months within normal limits without the need for pharmacologic intervention
- Current treatment with cholesterol lowering medications
- Chronic renal failure (creatinine clearance less than 50 ml)
- Known HIV infection
- HCV genotype 4, 5, 6 or mixed infection.
- Other causes of liver disease apart from hepatitis C (hepatitis B, alcoholic liver disease, NASH, autoimmune hepatitis, PBC etc.). Bland, non-alcoholic hepatic steatosis will not constitute an exclusion criterion
- History of trauma to the neck, surgery or deformity precluding sonographic visualization of the carotid arteries
- Inability to sign or understand the informed consent form
- A contraindication or unwillingness to undergo the coronary calcium score CT scan will not be an exclusion criterion, as this is not a primary end-point, as long as the participant is willing to undergo an IMT measurement.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Hepatitis C Eradication and Progression of Atherosclerosis
This study will examine the effects of treatment for hepatitis C on atherosclerosis, or hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can cause permanent damage to that organ. Treatment can clear the virus in at least half of patients and reduce the risk of serious complications of the disease. Atherosclerosis is an accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to chest pain, heart attack or stroke.
Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels. Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences. This study will determine what effect hepatitis C treatment has on the rate of atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.
Read more
Patients 30 years of age and older with current or past infection with hepatitis C may be eligible for this study. Participants undergo the following tests and procedures:
- Questionnaires regarding risk factors for heart disease and stroke
- Measurements of blood pressure, heart rate, weight, height, waist and hips
- Blood tests
- CT scans and ultrasound tests to measure the degree of blood vessel hardening and narrowing in the heart and neck region
Read the detailed description
Hepatitis C virus (HCV) infection is associated with changes in lipid metabolism in the liver and the peripheral blood. Patients with chronic hepatitis C infection tend to have low levels of cholesterol and LDL-cholesterol. These levels increase in many patients after treatment and successful eradication of the virus. However, it is not known whether this increase is associated with increased cardiovascular risk and thus may increase their risk for atherosclerotic disease. To determine whether eradication of HCV affects atherosclerosis progression, we propose to examine up to 200 patients with chronic hepatitis C for markers of atherosclerosis and the risk of its complications. Up to 100 patients who have cleared HCV and recovered will be matched and compared to patients who failed to respond and continue to have chronic hepatitis C. The atherosclerosis assessment will include careful history for cardiovascular risk factors, a battery of blood tests for lipid levels and relevant biomarkers followed by specialized imaging tests of the carotid and coronary arteries, including ultrasound imaging of intima-media thickness of the carotid arteries and computerized axial tomography of the heart and coronary arteries. The primary end point in the assessment will be differences in maximal carotid intima media thickness and secondary end points will include differences in coronary artery calcium score, Framingham risk scores and other measurements or atherosclerosis. This cross-sectional study will set the stage for a more formal prospective assessment of cardiovascular risk factors and evidence of coronary and cerebrovascular disease among patients being treated with antiviral agents.
- Conditions
- Chronic Hepatitis C, Atherosclerosis
- Keywords
- Hepatitis C Virus, Atherosclerosis, Intima-Media Thickness, Coronary Artery Calcium Score, Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Atherosclerosis, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-media thickness
Secondary outcomes (1)
Coronary calcium score, Framingham score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study start8 Apr 2008
- Study completion24 Mar 2015
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 Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Observational
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Yaron Rotman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659256
- Sponsor's protocol ID
- 080106
- Other IDs
- 08-DK-0106
- Status last verified
- 24 Mar 2015
- First submitted
- 15 Apr 2008
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Maggi G, Bottelli R, Gola D, Perricone G, Posca M, Zavaglia C, Ideo G. Serum cholesterol and chronic hepatitis C. Ital J Gastroenterol. 1996 Oct-Nov;28(8):436-40.
PubMed 9032585Moriya K, Shintani Y, Fujie H, Miyoshi H, Tsutsumi T, Yotsuyanagi H, Iino S, Kimura S, Koike K. Serum lipid profile of patients with genotype 1b hepatitis C viral infection in Japan. Hepatol Res. 2003 Apr;25(4):371-376. doi: 10.1016/s1386-6346(02)00309-1.
PubMed 12699847Jarmay K, Karacsony G, Nagy A, Schaff Z. Changes in lipid metabolism in chronic hepatitis C. World J Gastroenterol. 2005 Nov 7;11(41):6422-8. doi: 10.3748/wjg.v11.i41.6422.
PubMed 16425410
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Eradication and Progression of Atherosclerosis
- ClinicalTrials.gov ID
- NCT00659256
- Acronym / sponsor ID
- 080106
- Conditions
- Chronic Hepatitis C, Atherosclerosis
- Keywords
- Hepatitis C Virus, Atherosclerosis, Intima-Media Thickness, Coronary Artery Calcium Score, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 8 Apr 2008
- Study completion
- 24 Mar 2015
- First posted
- 16 Apr 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 will examine the effects of treatment for hepatitis C on atherosclerosis, or hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can cause permanent damage to that organ. Treatment can clear the virus in at least half of patients and reduce the risk of serious complications of the disease. Atherosclerosis is an accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to chest pain, heart attack or stroke.
Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels. Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences. This study will determine what effect hepatitis C treatment has on the rate of atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.
Patients 30 years of age and older with current or past infection with hepatitis C may be eligible for this study. Participants undergo the following tests and procedures:
- Questionnaires regarding risk factors for heart disease and stroke
- Measurements of blood pressure, heart rate, weight, height, waist and hips
- Blood tests
- CT scans and ultrasound tests to measure the degree of blood vessel hardening and narrowing in the heart and neck region
Detailed description
Hepatitis C virus (HCV) infection is associated with changes in lipid metabolism in the liver and the peripheral blood. Patients with chronic hepatitis C infection tend to have low levels of cholesterol and LDL-cholesterol. These levels increase in many patients after treatment and successful eradication of the virus. However, it is not known whether this increase is associated with increased cardiovascular risk and thus may increase their risk for atherosclerotic disease. To determine whether eradication of HCV affects atherosclerosis progression, we propose to examine up to 200 patients with chronic hepatitis C for markers of atherosclerosis and the risk of its complications. Up to 100 patients who have cleared HCV and recovered will be matched and compared to patients who failed to respond and continue to have chronic hepatitis C. The atherosclerosis assessment will include careful history for cardiovascular risk factors, a battery of blood tests for lipid levels and relevant biomarkers followed by specialized imaging tests of the carotid and coronary arteries, including ultrasound imaging of intima-media thickness of the carotid arteries and computerized axial tomography of the heart and coronary arteries. The primary end point in the assessment will be differences in maximal carotid intima media thickness and secondary end points will include differences in coronary artery calcium score, Framingham risk scores and other measurements or atherosclerosis. This cross-sectional study will set the stage for a more formal prospective assessment of cardiovascular risk factors and evidence of coronary and cerebrovascular disease among patients being treated with antiviral agents.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age equal to or greater than 30 years, male or female
- Written informed consent
- All ethnicities
- Cases:
- Genotype 1 controls:
Key exclusion criteria (17 listed)
- Pregnancy or lactation
- Ischemic cerebrovascular accident (CVA), transient ischemic accident (TIA) or radiological evidence of stroke.
- Proven coronary artery disease history of myocardial infarction, need for coronary angioplasty or coronary artery bypass graft, anginal syndrome with confirmatory stress test or cardiac imaging.
- Symptomatic peripheral vascular disease, history of angioplasty or surgical bypass.
- History of carotid artery surgery or angioplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intima-media thickness
1 secondary outcome
Coronary calcium score, Framingham score
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 12 Dec 2019.
- Background: PubMed 9032585Maggi G, Bottelli R, Gola D, Perricone G, Posca M, Zavaglia C, Ideo G. Serum cholesterol and chronic hepatitis C. Ital J Gastroenterol. 1996 Oct-Nov;28(8):436-40.
- Background: PubMed 12699847Moriya K, Shintani Y, Fujie H, Miyoshi H, Tsutsumi T, Yotsuyanagi H, Iino S, Kimura S, Koike K. Serum lipid profile of patients with genotype 1b hepatitis C viral infection in Japan. Hepatol Res. 2003 Apr;25(4):371-376. doi: 10.1016/s1386-6346(02)00309-1.
- Background: PubMed 16425410Jarmay K, Karacsony G, Nagy A, Schaff Z. Changes in lipid metabolism in chronic hepatitis C. World J Gastroenterol. 2005 Nov 7;11(41):6422-8. doi: 10.3748/wjg.v11.i41.6422.
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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.
Yaron Rotman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C and Atherosclerosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 20 inclusion and 17 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 12 Dec 2019. 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.
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?
Intima-media thickness. 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 NCT00659256, 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 12 Dec 2019.