Title: Epidemiology, Infectivity and Natural History of Hepatitis C
Virus Infection in a Blood Donor Population
Number: 91-CC-0117
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.


Sponsoring Institute:
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

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.

b) be 18 years of age or older.

c) 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.

d) provide informed consent.


EXCLUSION CRITERIA:


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


Special Instructions: Currently Not Provided
Keywords:
Hepatitis C Virus
Blood Donors
Liver Biopsy
ALT
Natural History
Recruitment Keyword(s):
None
Condition(s):
Hepatitis C
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
N/A

Contact(s):
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@...

Citation(s):
An assay for circulating antibodies to a major etiologic virus of
human non-A, non-B viral hepatitis genome

Routes of infection, viremia and liver disease in blood donors found
to have hepatitis C virus infection

The incidence of transfusion-associated hepatitis G virus infection
and its relation to liver disease




If you have:

Questions about participating in a study, please contact the Patient
Recruitment and Public Liaison Office, CC.
Technical questions regarding the Clinical Center web site, please
contact the Department of Networks and Applications, CC.