【medical-news】JID: 随机双盲1b期研究发现ITX5061具有一定的抗HCV作用
发布于 2013-10-27 · 浏览 927 · IP 黑龙江黑龙江
这个帖子发布于 11 年零 200 天前，其中的信息可能已发生改变或有所发展。
Background.?HepatitisC virus (HCV) entry involves scavenger receptor B1 (SRB1). In vitro, SRB1inhibition by ITX5061 impedes HCV replication.
Methods.?Multicenterstudy to assess safety/activity of ITX5061 in previously untreated,noncirrhotic, HCV genotype 1 infected adults. Design included sequentialcohorts of 10 subjects with ITX5061 (n = 8) or placebo (n = 2) to escalateduration (3 to 14 to 28 days) or deescalate dose (150 to 75 to 25 mg) based onpredefined criteria for safety and activity (≥4 of 8 subjects with HCV RNA decline ≥1 log10 IU/mL).
Results.?Thirtysubjects enrolled in 3 cohorts: ITX5061 150 mg/day by mouth for 3 (A150), 14(B150), and 28 (C150) days. Six subjects had grade ≥3 adverse events (one in placebo); nonewere treatment related. One of the 7 C150 subjects (14.3%, 95% confidenceinterval [CI], .7%-55.4%) had ≥1 log10 IU/mL decline in HCV RNA (1.49 log10 IU/mL), whereas none ofthe 6 placebo, 8 A150 or 8 B150 subjects showed such decline.
Conclusions.?OralITX5061 150 mg/day for up to 28 days was safe and well tolerated. In the 28-daycohort, 1 of 7 subjects showed antiviral activity; however, predefined criteriafor antiviral activity were not met at the doses and durations studied.
Methods.?Multicenterstudy to assess safety/activity of ITX5061 in previously untreated,noncirrhotic, HCV genotype 1 infected adults. Design included sequentialcohorts of 10 subjects with ITX5061 (n = 8) or placebo (n = 2) to escalateduration (3 to 14 to 28 days) or deescalate dose (150 to 75 to 25 mg) based onpredefined criteria for safety and activity (≥4 of 8 subjects with HCV RNA decline ≥1 log10 IU/mL).
Results.?Thirtysubjects enrolled in 3 cohorts: ITX5061 150 mg/day by mouth for 3 (A150), 14(B150), and 28 (C150) days. Six subjects had grade ≥3 adverse events (one in placebo); nonewere treatment related. One of the 7 C150 subjects (14.3%, 95% confidenceinterval [CI], .7%-55.4%) had ≥1 log10 IU/mL decline in HCV RNA (1.49 log10 IU/mL), whereas none ofthe 6 placebo, 8 A150 or 8 B150 subjects showed such decline.
Conclusions.?OralITX5061 150 mg/day for up to 28 days was safe and well tolerated. In the 28-daycohort, 1 of 7 subjects showed antiviral activity; however, predefined criteriafor antiviral activity were not met at the doses and durations studied.
最后编辑于 2022-10-09 · 浏览 927
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