drugset / Trial / NCT01272310

Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy.

NCT01272310

Phase 1/2 Unknown 36 enrolled Sheba Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.

Timeline

Start
2011-01
Primary completion
2012-01
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 200 mg Oral
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral