View Clinical Trial (Medical Research Study)
Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection in a Blood Donor Population
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Hepatitis C |
| Purpose: |
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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.
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| Study Summary: |
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At initiation of this study in 1991, approximately 0.6% of U.S. blood donors were identified
as having antibody to the hepatitis C virus (anti-HCV). This represented 72,000 of the
estimated 12 million annual U.S. blood donations. By investigating a cohort of anti-HCV
positive donors, this study aims to determine: 1) the primary routes of HCV transmission in
an asymptomatic donor population; 2) the relationship between anti-HCV and evidence of acute
or chronic liver disease; 3) the infectivity of anti-HCV positive individuals as judged by
measurement of HCV RNA and by investigation of their sexual partners and prior blood
recipients; 4) the chronic consequences of HCV infection. The study does not directly
provide treatment for HCV infection. Enrollment is limited to persons identified as anti-HCV
positive at the time of blood donation and persons from any source found to have clinical or
molecular evidence of acute hepatitis C virus infection. Although the primary goal of this
study is to investigate HCV infection and its outcomes, we occasionally encounter blood
donors or NIH patients who are infected with HBV or who have HCV-HBV coinfection. We will
enroll such patients to better understand HBV infection and to compare outcomes in those who
are HCV monoinfected, HBV monoinfected or who have HCV-HBV coinfection.
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| Criteria: |
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- 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:
1. be anti-HCV+ at the time of donation.
2. be 18 years of age or older.
3. 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.
4. 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.
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| NCT ID: |
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NCT00004850 |
| Primary Contact: |
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Principal Investigator
Harvey J Alter, M.D.
National Institutes of Health Clinical Center (CC)
Cathy Schechterly
Phone: (301) 496-4899
Email: cschechterly@mail.cc.nih.gov
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| Backup Contact: |
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Email: Harvey.Alter@nih.hhs.gov
Harvey J Alter, M.D.
Phone: (301) 496-8393
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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