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Clinical Trials
In July 2015, we announced that we intend to initiate a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects. These subjects will not be taking other antiviral medication. In the single ascending dose phase of the trial, subjects will be given a single dose of birinapant. The dose of birinapant will be escalated until at least one of the subjects shows evidence of activity, defined as an increase in liver transaminases and/or a decline in circulating viral DNA. At that point the cohort will be expanded and additional subjects will each receive four weekly administrations, at that dose, of birinapant. The starting dose of birinapant will be 2.8 mg/m2. We have retained a clinical research organization and currently expect to initiate this trial at multiple sites in India in early 2016. Timing of results will depend upon enrollment rates and upon the cohort in which activity, if any, is seen. |
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楼主: certainn
发表于 2015-8-9 08:47
