NIH Clinical Research Studies

Protocol Number: 00-DK-0221

Active Accrual, Protocols Recruiting New Patients

Title:
Evaluation of the Immune Response in Humans After Exposure to Hepatitis C Virus
Number:
00-DK-0221
Summary:
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.

Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA

Male or female;

All ethnic groups;

Age above 18 years;

Defined exposure to hepatitis C.

EXCLUSION CRITERIA

Subjects with a Hct of less than 30.

Special Instructions: Currently Not Provided
Keywords:
Hepatitis C
Exposure
Immune Response
Cytokines
Viral Sequence
PCR
T Cell
Seroconversion
Recruitment Keywords:
None
Conditions:
Hepatitis C
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Risk of hepatitis C seroconversion after occupational exposures in health care workers

A prospective study of hepatitis C virus infection after needlestick accidents

Study of needlestick accidents and hepatitis C virus infection in healthcare workers by molecular evolutionary analysis

Active Accrual, Protocols Recruiting New Patients

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