drugset / Trial / NCT01687257

Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

NCT01687257

Phase 2 Completed 50 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

Timeline

Start
2012-07
Primary completion
2015-01
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral