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首页> 外文期刊>Controlled clinical trials >Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders.
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Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders.

机译：HALT-C试验的演变：聚乙二醇化干扰素作为以往干扰素无反应者中慢性丙型肝炎的维持疗法。

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The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial was designed to determine whether maintenance interferon therapy could slow disease progression in patients who had failed to eradicate hepatitis C virus (HCV) during prior interferon treatment (nonresponders). Ten clinical sites, a virological testing center, and a data coordinating center (DCC) were selected to collaborate in the design and implementation of the final protocol. Eligible patients had been treated previously with interferon for at least 12 weeks, with or without another antiviral, ribavirin, but still had persistent viremia. Because patients had received a variety of prior treatments, and as a perceived benefit of enrollment, we incorporated a Lead-in period of treatment with long-acting pegylated interferon alfa-2a plus ribavirin into the study design, a combination believed to be more effective but not approved by the Food and Drug Administration at the Trial's inception. If patients failed to achieve clearance of virus from the blood after 20 weeks of this Lead-in therapy, they were entered into the main trial at week 24 and randomized to receive either a lower dose of pegylated interferon weekly alone or no further therapy for an additional 3 1/2 years. The original protocol was amended later in three respects to improve enrollment and to adapt to Food and Drug Administration approval of the Lead-in therapy, including allowing patients to proceed directly to the randomized part of the study if treatment resembling the Lead-in had been completed. The protocol changes enhanced enrollment while upholding the original goals of the study and its integrity.
机译：丙型肝炎抗肝硬化长期治疗（HALT-C）试验旨在确定维持干扰素治疗是否可以减慢在先前干扰素治疗期间未能消除丙型肝炎病毒（HCV）的患者的疾病进展（无反应者）。选择了十个临床站点，一个病毒学测试中心和一个数据协调中心（DCC）来合作设计和实施最终方案。符合条件的患者先前接受过干扰素治疗至少12周，有或没有其他抗病毒药物利巴韦林，但仍持续存在病毒血症。因为患者已经接受了各种先前的治疗，并且作为入组的明显好处，所以我们在研究设计中加入了长效聚乙二醇化干扰素α-2a加利巴韦林的导入治疗期，该组合被认为更有效但未经审判就获得了食品药品监督管理局的批准。如果患者在进行这种导入治疗20周后仍未能从血液中清除病毒，则他们将在第24周进入主要试验，并随机接受每周一次更低剂量的聚乙二醇化干扰素的治疗，或者不再接受进一步治疗。另外3 1/2年。最初的方案后来在三个方面进行了修改，以提高注册人数并适应食品和药物管理局对导入疗法的批准，包括如果已经进行了类似于导入疗法的治疗，则允许患者直接进行随机研究。完成。该方案改变了注册人数，同时坚持了研究的最初目标及其完整性。

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