Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection

NCT00004850 | Completed

• 2 other identifiers: 91011791-CC-0117
• Study Type: observational
• Target: 805
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive for antibodies to this virus. Most HCV-infected people do not become ill and are not aware that they have hepatitis or have had it in the past. Some infected people recover completely, whereas others remain chronically infected. The study will try to define infectivity of anti-HCV positive individuals, routes of transmission of the virus, and the number of HCV-infected persons who have evidence of liver disease. Blood donors at the NIH Clinical Center or the Central Maryland Chapter of the American Red Cross who test positive for HCV may be eligible for this study. Participants will have a physical examination and history, including questions about socioeconomic status and current sexual practices. They will have 100 milliliters (ml) (6 tablespoons) of blood drawn at the first visit and 50 ml (3 tablespoons) drawn 3, 6, 9 and 12 months after the initial visit. Some participants may undergo plasmapheresis, a procedure for collecting additional plasma (the liquid portion of the blood). For this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The plasma is then removed, and the red and white cells and platelets are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. In some individuals, other body fluids (saliva, urine or semen) may also be collected. Participants may be asked to bring their household contacts and sexual partners to NIH for interview and blood testing for evidence of HCV infection and liver disease. Although this is not required for participation in the study, it would provide additional valuable information. Participants found to have chronic viral infection will be seen more often and will provide additional blood samples for routine medical care. Further medical evaluation may include X-rays or liver scans and referral to a specialist for additional tests or therapy. Ten people in this study will be recruited to participate in a secondary investigation to analyze changes in the level of HCV and the immune response to it, and to relate these changes to the degree of liver damage. In addition to blood collected for the primary study, participants in this investigation will have an additional 50 ml (3 tablespoons) of blood drawn from an arm vein every week for 10 weeks to measure levels of virus, ALT (a liver enzyme), and immune response.

Conditions

Hepatitis C; Hepatitis B

Keywords

HCV Coinfection; Transfusion Transmission; Hepatitis C; Hepatitis B; Natural History

Outcome Measures

Primary Outcomes (1)

• Investigate HCV infection and its outcomes

  To determine clinical outcomes and long term sequelae of those infected with chronic HCV, HBV and coninfection HBV/HCV.

  Ongoing

Study Arms (3)

HBV positive

HBV positive subjects

HCV positive partners

HCV positive partner subjects

HCV postive

HCV positive subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is now closed to accrual but patients were selected from NIH Blood donors who were anti-HCV positive and who volunteered to be in the study.@@@

You may qualify if:

• Blood donors will be enrolled from among participants in the blood programs of the National Institutes of Health/Clinical Center/Department of Transfusion Medicine (NIH/CC/DTM) and the American Red Cross/Central Maryland Chapter/The Greater Chesapeake and Potomac Regional Blood Services (ARC).
• Enrollment will be restricted to those who test positive in the anti-HCV screening assay.
• To fulfill criteria for study entry, the donor must:
• a) be anti-HCV+ at the time of donation or
• otherwise be identified as having acute hepatitis C virus infection (Or, b) Have HBV infection as evidenced by the presence of HBsAg and/or HBV DNA with or without coexistent HCV infection
• be 18 years of age or older.
• be able/willing to travel to NIH for blood sampling 4 times in the first year of study and semi-annually thereafter and willing to have an annual history and physical examination.
• Be willing and able to provide informed consent.

You may not qualify if:

• Donors who do not consent or who do not meet eligibility criteria will be excluded from the study with appropriate explanation.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hepatitis C; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections

Study Officials

• Valeria De Giorgi, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2000
• First Posted: March 3, 2000
• Study Start: March 15, 1991
• Last Updated: May 22, 2026

Record last verified: 2025-07-08

Locations

US (1)