A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

Phase 3 Completed 311 enrolled AbbVie

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

Timeline

Start: 2013-03
Primary completion: 2014-11
Completion: 2015-07

Publications

Results Dore GJ, Conway B, Luo Y, Janczewska E, Knysz B, Liu Y, Streinu-Cercel A, Caruntu FA, Curescu M, Skoien R, Ghesquiere W, Mazur W, Soza A, Fuster F, Greenbloom S, Motoc A, Arama V, Shaw D, Tornai I, Sasadeusz J, Dalgard O, Sullivan D, Liu X, Kapoor M, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	—
Subject	Ribavirin	Small molecule	—	—
Comparator	Telaprevir	Small molecule	750 mg	—
Subject	dasabuvir	Small molecule	250 mg	—
Subject	ombitasvir	Small molecule	25 mg	—
Subject	paritaprevir	Small molecule	150 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before

Summary

Timeline

Publications

Drugs

Indications