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; Exposure; Immune Response; Cytokines; Viral Sequence; PCR; T Cell; Seroconversion
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.

--Back to Top--

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.

--Back to Top--

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

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information:
Theo Heller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9C432B MSC 1800 10 CENTER DR BETHESDA MD 20892-1800 (301) 402-7147 theoh@intra.niddk.nih.gov	Theo Heller, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health BG 10 RM 9C432B MSC 1800 10 CENTER DR BETHESDA MD 20892-1800 (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

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov