NCT00659256

Completed

Hepatitis C Treatment and Atherosclerosis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Source

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Other study identifiers

Sponsor study identifier

080106

Secondary identifiers

08-DK-0106

Study Type

observational

Actual enrollment (reported)

70

Locations

1 country

Sites

1

Timeline

Study Start

April 8, 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

March 24, 2015

Date type not reported

This date has not been verified as actual or estimated.

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 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 70 participants
Study completion date: March 24, 2015
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 8, 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 15, 2008
Actual (reported)
First Posted
April 16, 2008
Actual (reported)
Study Completion
March 24, 2015
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: December 12, 2019
Status Verified: March 24, 2015
Last Update Submitted: December 11, 2019

Conditions

Atherosclerosis Chronic Hepatitis C

Keywords

Hepatitis C VirusAtherosclerosisIntima-Media ThicknessCoronary Artery Calcium ScoreHepatitis C

Outcome Measures

Primary Outcomes (1)

Intima-media thickness

Secondary Outcomes (1)

Coronary calcium score, Framingham score

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age equal to or greater than 30 years, male or female
Written informed consent

Sponsors & Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Related Publications (3)

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.
PMID: 9032585BACKGROUND
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.
PMID: 12699847BACKGROUND

MeSH Terms

Conditions

Hepatitis C, ChronicAtherosclerosisHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic Disease

Study Officials

Yaron Rotman, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRINCIPAL INVESTIGATOR

Enrollment

70 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: OTHER
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 16, 2008

Study Start

April 8, 2008

Date type not reported

This date has not been verified as actual or estimated.

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NCT00546715

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Phase 1/2Completed

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Phase 2Completed

NCT02468648

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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

+5 more criteria

You may not qualify if:

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.
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

Contact the study team to confirm eligibility.

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.

PMID: 16425410BACKGROUND

Disease Attributes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Cardiovascular Diseases

Study Completion

March 24, 2015

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

December 12, 2019

Record last verified: 2015-03-24

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00659256
Data provider: ClinicalTrials.gov
Source updated: 2019-12-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:14 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations