Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
Completed
Santaris Pharma A/S
Phase 2
The main purpose of this study is to determine the safety and tolerability of multiple dosing
of miravirsen in subjects infected with chronic hepatitis C.
Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of
miravirsen's effect on HCV viral titer.
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
Unknown status
Santaris Pharma A/S
Phase 2
The purpose of this open-label study is to assess the safety, antiviral activity, and
pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over
5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12
weeks of treatment. The subjects enrolled in this study are chronically infected with HCV
genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Unknown status
Santaris Pharma A/S
Phase 2
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.
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