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Protocol Details

Evaluation of the Immune Response in Humans After Exposure to Hepatitis C Virus

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

00-DK-0221

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Hepatitis C;
Viral Sequence;
PCR;
T Cell;
Seroconversion;
Cytokines

Recruitment Keyword(s)

None

Condition(s)

Hepatitis C

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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.


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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

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Contacts:

Principal Investigator

Referral Contact

For more information:

Theo Heller, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C432B
10 CENTER DR
BETHESDA MD 20814
(301) 402-7147
theoh@intra.niddk.nih.gov

Theo Heller, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C432B
10 CENTER DR
BETHESDA MD 20814
(301) 402-7147
theoh@intra.niddk.nih.gov

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

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00006301

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