The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Fundacion de Investigacion de Diego
San Juan, Puerto Rico
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Time frame: 42 weeks
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Time frame: 18 weeks
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Time frame: 66 Weeks
Change in HCV RNA levels from baseline throughout the study.
Time frame: 66 Weeks
The proportion of subjects who experience virological failure throughout the study.
Time frame: 66 Weeks
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