JPRN-jRCT2080222042未知3 期
A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naive or Prior Relapsers to Alfa/RBV Therapy
Bristol-Myers K.K.0 个研究点目标入组 450 人开始时间: 2013年3月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients chronically infected with HCV Genotype-1b
- •Naive to prior treatment or documented evidence of relapse after 48 weeks of treatment with alfa/Ribavirin (RBV)
- •HCV RNA viral load 100,000 copies/mL and more at screening
排除标准
- •Infection with Hepatitis C virus (HCV) other than Genotype-1b
- •Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
- •Evidence of chronic liver disease caused by diseases other than chronic HCV infection
- •Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
- •Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- •Laboratory values:
- •1.Hemoglobin < 12.0 g/dL (males) or < 11.0 g/dL (females)
- •2.Platelets < 90,000/mm3
- •3.Total serum bilirubin 2 mg/dL and more (unless due to Gilbert's disease)
研究者
相似试验
进行中（未招募）
不适用
Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapyChronic Hepatitis C Virus Infection (Genotype 1b)MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005409-65-DEBristol-Myers Squibb International Corporation585
进行中（未招募）
1 期
Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapyChronic Hepatitis C Virus Infection (Genotype 1b)MedDRA version: 16.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2011-005409-65-GBBristol-Myers Squibb International Corporation641
进行中（未招募）
不适用
Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapyChronic Hepatitis C Virus Infection (Genotype 1b)MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005409-65-PLBristol-Myers Squibb International Corporation585
进行中（未招募）
不适用
Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapyChronic Hepatitis C Virus Infection (Genotype 1b)MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 100000004862EUCTR2011-005409-65-ESBristol-Myers Squibb International Corporation585
进行中（未招募）
不适用
Efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (Lambda + RBV + DCV) in HCV genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + RBV) therapyEUCTR2011-005409-65-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO585