Status:
COMPLETED
Hepatitis C Treatment and Atherosclerosis
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Hepatitis C
Atherosclerosis
Eligibility:
All Genders
30+ years
Brief 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 dama...
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 cholester...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 8 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 24 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00659256
Start Date
April 8 2008
End Date
March 24 2015
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892