TREATMENT OF CHRONIC HEPATITIS C WITH AMANTADINE HC1

用盐酸金刚烷胺治疗慢性丙型肝炎

• 批准号: 2873757
• 负责人: Jill P Smith
• 金额: $ 12.88万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2873757
• 关键词: amantadine; chronic disease /disorder; clinical research; clinical trials; drug administration rate /duration; drug screening /evaluation; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; liver disorder chemotherapy; quality of life; virus replication

Treatment of hepatitis C has been disappointing with less than one-third achieving a sustained response and most experiencing significant side effects. Although Interferon is the only FDA approved drug for the treatment of hepatitis C in adults, it is not approved for children. A pilot trial was conducted at Pennsylvania State University, College of Medicine in which adult patients with hepatitis C who had failed to respond to interferon were treated with amantadine-HC1 for six months. Serum alanine aminotransferase values decreased in 64 percent of the patients with amantadine therapy compared to intervals without therapy or to interferon therapy. Twenty-seven percent of patient treated with amantadine had normalization of ALT values and loss of hepatitis C virus RNA. Promising results of the pilot study are reason for further investigation. This grant hypothesizes that administration of amantadine-HC1 to patients with chronic hepatitis C will inhibit hepatic inflammation by repressing replication of the hepatitis C virus. We propose to investigate this hypothesis by conducting a prospective randomized double-blind placebo-controlled trial in 100 adult and 50 pediatric patients with chronic hepatitis C. The following specific aims are proposed: 1) Evaluate the efficacy of amantadine as an active antiviral agent for hepatitis C in adult patients who had previously failed therapy with interferon, 2) Study the safety and efficacy of amantadine in children with hepatitis C infection, 3) Evaluate the effects of amantadine on hepatic inflammation and hepatitis C RNA blood levels in naive patients who either decline from interferon therapy or who cannot take interferon for medical reasons, 4) Study response rate and durability of response in patients treated with six versus 12 months of amantadine, and 5) elucidate be effects of amantadine therapy on the patient's quality of lift. These studies are part of one long term goals towards understanding the mechanisms involved in infection and treatment of the hepatitis C virus.

丙型肝炎的治疗效果令人失望，只有不到三分之一 实现持续的反应和最有经验的重要方面 影响。 尽管干扰素是 FDA 唯一批准的治疗该疾病的药物 用于治疗成人丙型肝炎，尚未批准用于儿童。 宾夕法尼亚州立大学学院进行了一项试点试验 医学杂志，其中未能接受治疗的成年丙型肝炎患者 对干扰素有反应的患者接受金刚烷胺-HC1 治疗六个月。 64% 的人血清丙氨酸氨基转移酶值下降 接受金刚烷胺治疗的患者与未接受治疗的间隔期相比 或干扰素治疗。 百分之二十七接受治疗的患者 金刚烷胺使 ALT 值正常化并消除丙型肝炎病毒 核糖核酸。 试点研究的可喜结果是进一步开展研究的理由 调查。 这笔赠款假设管理 金刚烷胺-HC1对慢性丙型肝炎患者会抑制肝脏 通过抑制丙型肝炎病毒的复制来消除炎症。 我们 提议通过进行前瞻性研究来研究这一假设 在 100 名成人和 50 名成人中进行的随机双盲安慰剂对照试验 患有慢性丙型肝炎的儿科患者。具体如下 提出的目标是： 1) 评估金刚烷胺作为活性药物的功效 用于既往患有丙型肝炎的成年患者的抗病毒药物 干扰素治疗失败，2）研究其安全性和有效性 金刚烷胺用于丙型肝炎感染儿童，3) 评估 金刚烷胺对肝脏炎症和丙型肝炎RNA血液的影响 未接受干扰素治疗或拒绝接受干扰素治疗的初治患者中的水平 因医疗原因不能服用干扰素的人，4) 研究反应率 治疗 6 个月与 12 个月的患者的反应持久性 金刚烷胺的作用，以及 5) 阐明金刚烷胺疗法对 患者的移位质量。 这些研究是一项长期研究的一部分 目标是了解感染和相关机制 丙型肝炎病毒的治疗。