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- 2016-5-25
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hepatitis B virus, or HBV
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.
从官网上看的:http://tetralogicpharma.com/clinical-trials/
百度翻译:乙肝病毒,HBV
2015年七月,我们宣布,我们打算启动一个组合单剂量递增/多剂量递增临床试验中,与birinapant作为一个单一的药物,在慢性乙型肝炎组。这些受试者将不会采取其他抗病毒药物。在单一的提升试验剂量阶段,受试者将给予单剂量的birinapant。对birinapant剂量将升级到主体的至少一个显示的活动,定义为肝转氨酶和/或循环病毒DNA下降增加。在这一点上,队列将扩大和额外的受试者每人将获得四周的行政管理,在该剂量的birinapant。birinapant的起始剂量是2.8毫克/平方米。我们保留了一个临床研究组织预计在2016年初在印度多个地点发起这项试验。时间的结果将取决于入学率和在队列中的活动,如果有的话,是。 |
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