drugset
drugset / Trial / NCT03833362

Efficacy and Safety of Narlaprevir Used in Combination With Ritonavir in Treatment-Naïve and Failed Prior Treatment With Pegylated Interferon/Ribavirin Patients With Chronic Hepatitis C Genotype 1 (PIONEER - Study)

NCT03833362 ↗

Phase 3 Completed 420 enrolled R-Pharm
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to confirm that combination of narlaprevir (NVR) and ritonavir (RTV) used as a metabolic inhibitor with pegylated interferon (PEG-INF) and ribavirin (RBV) leads to a superior Sustained Virological Response (SVR) rate compared to treatment with pegylated interferon and ribavirin in treatment-naïve and treatment failure patient populations.

Timeline

Start
2014-05-07
Primary completion
2016-03-23
Completion
2017-02-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Narlaprevir Small molecule 200 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Background Ribavirin Small molecule 800 mg Oral
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral
Background Ribavirin Small molecule 1400 mg Oral

Indications

chronic hepatitis C virus infection