Immune Response to Hepatitis C Virus
This study will identify and characterize immune factors involved in hepatitis C infection and elimination of the virus. Individual responses to hepatitis C infection vary; some people are able to eliminate the virus, whereas others remain chronically infected. This study may identify factors important in preventing infection that may be of help in developing a vaccine or more effective treatments.
People over 18 years old who have been exposed to hepatitis C virus may participate in this study. Subjects will be recruited from the National Institutes of Health, Inova Fairfax Hospital, Occupational Medical Services-IDP P.C., Washington Hospital Center and Holy Cross Hospital, all in the Washington, D.C. metropolitan area. Individual patients from other centers will also be recruited on a case by case basis.
Participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. The first collection will be as soon as possible after exposure to hepatitis C virus and then again at 2, 4, 6, 12, 24, and 48 weeks after exposure. The white blood cells will be studied for their response to the virus, and markers for infection will be followed. If infection develops, additional samples of blood may be requested, and patients will be offered evaluation for treatment. Test results will be kept confidential and will not be entered into any medical records.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the Immune Response in Humans After Exposure to Hepatitis C Virus|
|Study Start Date:||September 24, 2000|
|Estimated Study Completion Date:||March 24, 2015|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006301
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, D.C., District of Columbia, United States, 20010|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Holy Cross Hospital, Silver Spring|
|Silver Spring, Maryland, United States, 20902|
|United States, Virginia|
|Occupational Medicine Services|
|Annandale, Virginia, United States, 22003|
|INOVA Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Theo Heller, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|