Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004850
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2000-03-02
Brief Title:
Epidemiology Infectivity and Natural History of Hepatitis C Virus Infection
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Epidemiology Infectivity and Natural History of Hepatitis C Virus Infection in a Blood Donor Population
Status:
COMPLETED
Status Verified Date:
2024-08-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
At initiation of this study in 1991 approximately 06 of US blood donors were identified as having antibody to the hepatitis C virus anti-HCV This represented 72000 of the estimated 12 million annual US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-CC-0117 | None | None | None |