Investigation of HCV Transmission, Infectivity and Long-Term Effects in Asymptomatic Blood Donors
This study aims to investigate the outcomes and long-term effects of Hepatitis C Virus (HCV) infection in asymptomatic blood donors, including those also infected with Hepatitis B Virus (HBV).
Data Collection
Collected from today forward - ProspectiveBlood-Borne Infections+11
+ Communicable Diseases
+ Digestive System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 15, 1991
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.805 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps