A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

Description

To explore the antiviral efficacy of combination therapy with sofosbuvir/ledipasvir fixed-dose combination ribavirin for 12 or 24 weeks in patients with advanced liver disease. Study designed with A cohort and B cohort.

Details
Clinical Study IdentifierTX137411
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, Age 18 years
Chronic genotype 1 and 4
HCV RNA infection with quantifiable virus at Screening
A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Day 1 visit
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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