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Épidémiologie, infectiosité et histoire naturelle de l'infection par le virus de l'hépatite C

Épidémiologie, infectiosité et histoire naturelle de l'infection par le virus de l'hépatite C dans une population de donneurs de sang

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

805

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • National Institutes of Health Clinical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study is now closed to accrual but patients were selected from NIH Blood donors who were anti-HCV positive and who volunteered to be in the study.@@@

La description

  • 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. 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

  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. Be willing and able to 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
HBV positive

HBV positive subjects

HCV positive partners

HCV positive partner subjects

HCV postive

HCV positive subjects

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Investigate HCV infection and its outcomes
Délai: Ongoing

To determine clinical outcomes and long term sequelae of those infected with chronic HCV, HBV and coninfection HBV/HCV.

Ongoing

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Valeria De Giorgi, Ph.D., National Institutes of Health Clinical Center (CC)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 mars 1991

Dates d'inscription aux études

Première soumission

2 mars 2000

Première soumission répondant aux critères de contrôle qualité

2 mars 2000

Première publication (Estimé)

3 mars 2000

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 octobre 2026

Dernière vérification

2 octobre 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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