Pilot study of pegylated interferon alpha 2a add on therapy in chronic hepatitis B patients under tenofovir administration - Peg-IFN add on therapy to tenofovir

Shinshu University0 个研究点目标入组 83 人开始时间: 2015年12月15日最近更新: 2023年10月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Shinshu University
入组人数: 83

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

A prospective study of TDF and P-IFN add-on therapy was conducted. Patients with chronic hepatitis B receiving TDF therapy were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). At 96 weeks after baseline, 41% of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% in the control arm (P < 0.001).

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Patients who have liver cirrhosis or hepatic failure. 2) Patients who have a complication of hepatocellular carcinoma or those who have a past history of it. 3) Patients with liver diseases which may affect clinical course of hepatitis B such as auoimmune hepatitis and alcoholic liver diseases. 4) Patients who have severe dysfunctions of organs other than the liver such as renal dysfunction and heart failure. 5) Patients who have a contraindication for pegylated interferon alha-2a in those who are assigned to pegylated-interferon add on therapy group. 6) Patients who are judged to be not eligible for the present study by corresponding physicians.

研究者

发起方

Shinshu University

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