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首页> 外文会议>International Symposiumn on Thymosins in Health and Disease; 20070321-24; Washington,DC(US) >Studies of Therapy with Thymosin α 1 in Combination with Pegylated Interferon α2a and Ribavirin in Nonresponder Patients with Chronic Hepatitis C
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Studies of Therapy with Thymosin α 1 in Combination with Pegylated Interferon α2a and Ribavirin in Nonresponder Patients with Chronic Hepatitis C

机译：胸腺素α1联合聚乙二醇化干扰素α2a和利巴韦林治疗慢性丙型肝炎无反应者的研究

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Despite the use of combination therapy with pegylated interferon a 2a (peg-IFN-α2a) + Ribavirin, a large proportion of patients with chronic hepatitis C (CHC) remain unresponsive to treatment. Thymosin alpha 1 (Tαl) is an immunomodulator, which displays immunological and antiviral activities against hepatitis C virus (HCV) in preclinical clinical settings. The purpose of this study was to evaluate the efficacy and safety of a triple combination therapy with peg-IFN-α2a + Ribavirin + Tα1 in CHC patients who were nonresponders to a previous course with peg-IFN-α2a + Ribavarin. The primary endpoint is the rate of sustained virological response (SVR). We designed a phase 3, randomized, double-blind, multicenter, prospective, placebo controlled study. Patients meeting selection criteria were randomized centrally (through IVR system) to receive either peg-IFN-α2a 180 mcg s.c. once weekly + Ribavirin 1000-1200 mg p.o. daily + Tα1 1.6 mg s.c. twice weekly for 24 weeks. Patients who remained HCV-RNA positive after 24 weeks stopped treatment and were considered nonresponders. HCV-RNA negative patients continued treatment up to week 48. All patients were followed up for 24 additional weeks after the end of treatment for the evaluation of the SVR. From December 2004 to November 2006, 638 patients were screened in 52 European sites. Preliminary blinded safety analysis suggests that both regimens are well tolerated. Efficacy evaluation will be available after the opening of this blinded phase 3 trial, planned for May 2008.
机译：尽管使用了聚乙二醇化干扰素a 2a（peg-IFN-α2a）+利巴韦林的联合治疗，但大部分慢性丙型肝炎（CHC）患者仍对治疗无反应。胸腺素α1（Tα1）是一种免疫调节剂，在临床前临床环境中显示出针对丙型肝炎病毒（HCV）的免疫和抗病毒活性。这项研究的目的是评估peg-IFN-α2a+利巴韦林+Tα1的三联联合治疗对先前对peg-IFN-α2a+利巴伐林治疗没有反应的CHC患者的疗效和安全性。主要终点是持续病毒学应答（SVR）的速率。我们设计了一项3期，随机，双盲，多中心，前瞻性，安慰剂对照研究。将符合选择标准的患者集中（通过IVR系统）随机接受peg-IFN-α2a180 mcgs.c。每周一次+利巴韦林1000-1200 mg p.o.每天+Tα11.6 mg s.c.每周两次，共24周。在24周后仍保持HCV-RNA阳性的患者停止治疗，被视为无反应。 HCV-RNA阴性的患者继续治疗直至48周。所有患者在治疗结束后又接受了24周的随访，以评估SVR。从2004年12月到2006年11月，在欧洲的52个地点筛查了638名患者。初步的盲法安全性分析表明，两种方案均耐受良好。这项计划于2008年5月进行的第3阶段盲法试验开始后，即可进行疗效评估。

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