- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659256
Hepatitis C Treatment and Atherosclerosis
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.
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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
- 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
EXCLUSION CRITERIA:
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
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Intima-media thickness
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Secondary Outcome Measures
Outcome Measure |
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Coronary calcium score, Framingham score
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Collaborators and Investigators
Publications and helpful links
General 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.
- Moriya 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.
- Jarmay 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Atherosclerosis
Other Study ID Numbers
- 080106
- 08-DK-0106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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