A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus

Phase 2 Completed 90 enrolled Janssen R&D Ireland

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to explore the efficacy and safety of TMC647055, TMC435, and low-dose ritonavir, administered together with and without ribavirin and of TMC647055, TMC435, low-dose ritonavir administered together with GSK233680k without ribavirin in a limited number of patients with chronic hepatitis C virus (HCV) infection.

Timeline

Start: 2012-10
Primary completion: 2014-09
Completion: 2014-12

Publications

Vijgen L, Thys K, Vandebosch A, Van Remoortere P, Verloes R, De Meyer S. Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845. Virol J. 2017 May 31;14(1):101. doi: 10.1186/s12985-017-0760-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK2336805	Unknown	30 mg	Oral
Subject	GSK2336805	Unknown	60 mg	Oral
Subject	Ribavirin	Small molecule	200 mg	Oral
Subject	Simeprevir	Small molecule	75 mg	Oral
Subject	TMC647055	Small molecule	150 mg	Oral
Background	Pegylated interferon alpha-2a (PegIFN)	Unknown	180 ug	Subcutaneous
Background	Ritonavir	Other / unclassified	30 mg	Oral
Background	Ritonavir	Other / unclassified	50 mg	Oral

A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus

Summary

Timeline

Publications

Drugs

Indications