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Phase I/II Randomized Open-Label Dose-Finding Study of IdB 1016 in Hepatitis C (UW collaboration, Bastyr subcontractor)
The aim of this study is to gather evidence for dose-dependent safety and tolerability of an oral silybinphosphatidylcholine phystosome (Siliphos TM) at three doses in subjects with chronic hepatitis C with stages II, III, and IV of liver fibrosis. Effects will be measured by certain changes that occur during the 12-week treatment and the 4-week follow-up. This study will determine an optimal dose based on measured safety, tolerability and therapeutic effects for a future phase II randomized double blind, placebo-controlled clinical trial.