drugset
drugset / Trial / NCT02583685

Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

NCT02583685 ↗

Phase 2 Completed 138 enrolled Humanity and Health Research Centre Beijing 302 Hospital · collabNanfang Hospital, Southern Medical University · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

Timeline

Start
2015-05-15
Primary completion
2024-10-31
Completion
2024-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 200 mg Oral
Subject Simeprevir Small molecule 150 mg Oral
Background Ledipasvir/sofosbuvir Unknown 90 mg Oral
Background Ledipasvir/sofosbuvir Unknown 400 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral

Indications

chronic hepatitis C virus infection