EUCTR2011-005446-35-IE进行中（未招募）不适用
A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment- Naive Subjects with Chronic Hepatitis C Genotype 1b InfectionRevised Protocol Number 03, Incorporates amendment 04 dated 14-Jun-2013 - Hallmark DUA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and females, = 18 years of age;
- •HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with cirrhosis, OR treatment naive;
- •HCV RNA = 104 IU/mL (10,000 IU/mL);
- •Seronegative for HIV and HBsAg;
- •Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Prior treatment of HCV with HCV direct acting antiviral (DAA);
- •Evidence of a medical condition contributing to chronic liver disease other than HCV;
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
- •Diagnosed or suspected hepatocellular carcinoma or other malignancies;
- •Uncontrolled diabetes or hypertension;
研究者
相似试验
进行中（未招募）
不适用
PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles. Naives)EUCTR2011-005446-35-ESBristol-Myers Squibb International Corporation1,100
已完成
3 期
A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)Chronic Hepatitis C infection or Chronic HCV10047438Hepatitis CNL-OMON37621Bristol-Myers Squibb18
进行中（未招募）
不适用
PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles. Naives)HEPATITIS C VIRUSMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005446-35-DEBristol-Myers Squibb International Corporation1,100
进行中（未招募）
1 期
PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles. Naives)HEPATITIS C VIRUSMedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2011-005446-35-GBBristol-Myers Squibb International Corporation975
进行中（未招募）
不适用
PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles.Naives)HEPATITIS C VIRUSMedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005446-35-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO1,100