Completed

Investigation of HCV Transmission, Infectivity and Long-Term Effects in Asymptomatic Blood Donors

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Study Aim

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).

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood-Borne Infections+11

+ Communicable Diseases

+ Digestive System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 1991
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: October 6, 2026
Sourced from a government-validated database.Claim as a partner

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.

NCT00004850
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: October 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

805 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepadnaviridae InfectionsHepatitis BHepatitis C

Criteria

6 inclusion criteria required to participate
Be willing and able to provide informed consent

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

a) be anti-HCV+ at the time of donation or otherwise be identified as having acute hepatitis C virus infection (Or, b) Have HBV infection as evidenced by the presence of HBsAg and/or HBV DNA with or without coexistent HCV infection

Show More Criteria

1 exclusion criteria prevent from participating
Donors who do not consent or who do not meet eligibility criteria will be excluded from the study with appropriate explanation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

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
CompletedOne Study Center