Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

Phase 3 Completed 881 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Timeline

Start: 2012-06-14
Primary completion: 2015-02-04
Completion: 2015-05-15

Publications

Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon Lambda-1a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral
Background	Telaprevir	Small molecule	750 mg	Oral

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

Summary

Timeline

Publications

Drugs

Indications