ARC-520

hao2014

应该是2B吧？？

不用到明年3月吧？？？不过也早不了几个月，最快也得年底了

阳光醉人

回复 我的滑板鞋 的帖子

你是浙江的吗？

战天斗hbv

回复 hao2014 的帖子

临床实验网上写的2期，明年3月

我的滑板鞋

阳光醉人 发表于 2015-3-5 15:21
回复 我的滑板鞋 的帖子

你是浙江的吗？

不是

newchinabok

arc520新试验

https://www.clinicaltrials.gov/c ... m=arc520&rank=1

newchinabok

Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Detailed Description       
This is a single-center, open-label study of ARC-520 in combination with entecavir or tenofovir administered to patients with immune active chronic HBV infection. An iterative trial design is anticipated with potential inclusion of additional cohorts with anticipated enrollment of up to 60 patients. Patients who have signed a Human Research Ethics Committee approved informed consent, and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir (0.5-1.0 mg/day) or daily oral tenofovir (300 mg/day) and a single IV injection of ARC-520. If a serious adverse event (SAE) deemed possibly or probably related to study drug should occur at any point during the study, any further dosing will be put on hold pending a complete review of safety data by the sponsor and the Principal Investigator. Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, AEs, 12-lead ECGs, concomitant medication, blood sample collection for hematology, coagulation, chemistry, PK and exploratory PD measures, HBV virology. Patients will be monitored for a total of 12 weeks. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up.

newchinabok

慢性HBV感染者将获得ARC-520联合恩替卡韦和替诺福韦以及安全性和有效性进行评估。

详细说明
这是一个单中心，ARC-520在使用恩替卡韦和替诺福韦给予患者的免疫激活慢性HBV感染合并开放性研究。一个反复的试验设计，预计有可能列入更多的同伙与多达60名患者的预期招生。谁签署了人类研究伦理委员会批准的患者知情同意，并符合所有的协议资格，将继续接受每日口服恩替卡韦（0.5-1.0毫克/天）或每日口服替诺福韦（300毫克/天）和一个四注射ARC-520。如果一个严重不良事件（SAE）认为可能或很可能与研究药物在研究期间应该发生在任何时候，任何进一步的加药将被搁置未决安全数据由赞助商和首席研究员进行全面审查。患者将接受在研究过程中定期进行下列评价：病史，身体检查，生命体征测量结果（血压，心脏速率，呼吸速率，和温度），体重，不良事件，12导联心电图，伴随药物，血液试样收集血液，凝固，化学，PK和探索PD措施，乙肝病毒学。患者将总共12周进行监测。临床显著的变化，包括AES公司将遵循直到分辨率，待病情稳定后，直到事件另有解释，或直到患者失去随访。

newchinabok

Recruiting
Estimated Enrollment  ICMJE        60
Estimated Completion Date        March 2016
Estimated Primary Completion Date        December 2015   (final data collection date for primary outcome measure)

newchinabok

招聘
预计招生60 ICMJE
预计完工日期2016年3月
估计主要完成日期2015年12月（最终数据收集日期为主要测量指标）

战天斗hbv

回复 newchinabok 的帖子

和birinapant一样联合核苷类，我认为，我觉得，肯定是单药520效果不好～