drugset

drugset / Trial / NCT00780416

Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

NCT00780416 ↗

Phase 3 Completed 189 enrolled Tanabe Pharma Corporation Vertex Pharmaceuticals Incorporated · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.

Timeline

Start: 2008-11
Primary completion: 2010-08
Completion: 2010-08

Publications

Results Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.016. Epub 2011 Aug 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telaprevir	Small molecule	750 mg	—
Background	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	—
Background	Ribavirin	Small molecule	600 mg	—
Background	Ribavirin	Small molecule	1000 mg	—

Indications