drugset / Trial / NCT01727271

A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384)

NCT01727271

Phase 4 Withdrawn Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare monotherapy with tenofovir to sequential therapy with pegylated interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3 treatment arms.

Timeline

Start
2013-08
Primary completion
2017-08
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Subject Tenofovir Small molecule 300 mg Oral