Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

Phase 3 Unknown 40 enrolled Theodor Bilharz Research Institute

RandomizedParallel-groupOpen-labelTreatment

Summary

Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.

Timeline

Start: 2013-12
Primary completion: 2015-12
Completion: 2015-12

Publications

Background Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boceprevir	Small molecule	800 mg	Oral
Background	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	Subcutaneous
Background	Ribavirin	Small molecule	800 mg	—
Background	Ribavirin	Small molecule	1400 mg	—

Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

Summary

Timeline

Publications

Drugs

Indications