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A Registry for Cirrhosis that has a Sustained Virologic Response Following Sofosbuvir-Based Treatment without Interferon, for Patients who have Chronic Hepatitis C Infection

Overview

Información sobre este estudio

The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Willing and able to provide written informed consent
  • Has either previously participated in a Gilead-sponsored HCV study (or at pre-selected sites only) and received
    • A sofosbuvir-containing regimen without interferon 
      • Must achieve SVR as defined in the treatment protocol
      • Has liver cirrhosis, as defined in the treatment protocol
      • Has not had a liver transplant after receiving a SOF-containing regimen
    • An all-oral SOF-based regimen (outside a clinical study)
      • Must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12
      • SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment
      • Will have had cirrhosis confirmed prior to initiation of HCV treatment

Exclusion Criteria

  • Planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
  • History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Kymberly Watt, M.D.

Cerrado para la inscripción

More information

Publicaciones

  • Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis. In this international collaboration, we sought to develop a global universal HCC risk score to predict the HCC development for patients with chronic hepatitis. Read More on PubMed

Otros temas en investigación

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CLS-20308367

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