A Randomized, Blinded, Phase IIb Trial of Telbivudine (LdT) Versus the Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients With Chronic Hepatitis B

Novartis3 个研究点分布在 3 个国家目标入组 130 人开始时间: 2005年5月1日最近更新: 2017年6月16日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis
入组人数: 130
试验地点: 3

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Clinical history compatible with compensated chronic hepatitis B
•Other protocol-defined inclusion criteria may apply.

排除标准

•Patient is pregnant or breastfeeding
•Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
•Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.
•Other protocol-defined exclusion criteria may apply.

研究者

发起方

Novartis

申办方类型

Industry

研究点 (3)

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