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ARC520 临床试验
在澳大利亚和新西兰
研究ARC-520与或没有与于慢性乙肝治疗（Monarch）等药物
https://clinicaltrials.gov/ct2/s ... =ARC-520&rank=4
Detailed Description:
This is a multicenter, open-label study of ARC-520 based treatment regimens administered to patients with HBeAg positive or HBeAg negative immune active chronic Hepatitis B Virus (HBV) infection. Eligible patients naive to previous treatment, and who have signed an Ethics Committee - approved informed consent, will be enrolled and will receive ARC-520 alone or ARC-520 plus additional treatments such as entecavir (ENT) and pegylated interferon alpha 2a (PEG IFN) therapy. The study may initially involve up to a total of 72 eligible chronic HBV infected patients. Patients in all cohorts will receive a total of 13 doses of ARC-520 at a dose of 2 mg/kg. 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, adverse events assessment (AEs), 12-lead ECGs, liver fibrosis testing, concomitant medication assessment, blood sample collection for hematology, coagulation, chemistry, exploratory Pharmacodynamic (PD) measures, urinalysis, HBV serology, cytokines, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. 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. For each patient, the duration of the study is approximately 96 weeks, from enrolment to last visit. Prior to enrolment there is a 60 day screening period. Addition of new cohorts and additional treatment regimens are anticipated for this study.
详细说明：
这是给予患者HBeAg阳性或HBeAg阴性的免疫活动性慢性乙型肝炎病毒（HBV）感染的ARC-520基础的治疗方案的多中心，开放性研究。符合条件的患者天真的既往治疗，和谁已经签署了一项道德委员会 - 批准的知情同意书，将参加，并将获得ARC-520单独或ARC-520再加上额外的处理，如恩替卡韦（ENT）和聚乙二醇化干扰素α2a干扰素（PEG干扰素）治疗。这项研究最初可能涉及多达一共有72资格慢性HBV感染者。在所有的同伙患者将在2毫克/千克的剂量获得总计13剂量的ARC-520。患者将在研究期间经历定期下列评价：病史，身体检查，生命体征测量（血压，心脏，呼吸率，和温度），体重，不良事件的评估（AES），12导联心电图，肝纤维化试验，伴随药物评估，血液学，凝血，化学，探索性的药效学（PD）的措施，尿分析，HBV血清学，细胞因子的血液样品采集，促卵泡激素（FSH）的测试（绝经后女性）和怀孕测试女性的生育能力。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。对于每一个病人，研究的持续时间约96周，从报名到最后一次访问。在注册之前有60天的筛选期。增加新的同伙和额外的治疗方案，预计在本次研究。 |
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楼主: bigben446
发表于 2015-10-16 07:21
