EUCTR2011-003067-30-ES进行中（未招募）不适用
A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)+ Pharmacogenetics Blood Sample Amendment 01, version 1.0 dated 06-Oct-11
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
- 500
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 to 70 years of age;
- •?HCV Genotype 1a or 1b;
- •?HCV-Treatment naive;
- •?HCV RNA > 10,000 IU/mL at screening;
- •?HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART);
- •?For subjects receiving HAART, HIV RNA must be below < 40 copies/mL at screening and must be < 400 copies/ml for at least 6 months prior to screening;
- •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 475
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •?Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1;
- •?Subjects (receiving HAART) who have changed their anti-retroviral
- •regimen within the last 3 months prior to Day 1 (other than prohibited HAART regimens (see section 3.4.1), which may be substituted at least one month prior to Day 1);
- •?Use of prohibited HAART;regimens (see section 3.4.1) within one month of Day 1 and throughout the treatment period of the trial;
- •?Laboratory values:
- •neutrophil count < 1500 cells/?L (<1200 cells/ ?L for blacks), platelet count < 90,000 cells/?L, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males;
- •?Total bilirubin ? 34 ?mol/L (or ? 2 mg/dL) unless subject has a documented history of Gilbert?s disease or antiretroviral regimen contains atazanavir.
研究者
相似试验
进行中（未招募）
不适用
Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV VirusChronic Hepatitis C / HIV-1 co-infectionMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-003067-30-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO500
进行中（未招募）
1 期
Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV VirusChronic Hepatitis C / HIV-1 co-infectionMedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2011-003067-30-GBBristol-Myers Squibb International Corporation549
进行中（未招募）
不适用
A Phase 3, Open Label Study of Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture - Open Label Study of AA4500 in Subjects with Dupuytren's ContractureDupuytren's ContractureMedDRA version: 8.1Level: LLTClassification code 10013872Term: Dupuytren's contractureEUCTR2006-006143-31-SEAuxilium UK Limited240
进行中（未招募）
不适用
Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV VirusChronic Hepatitis C / HIV-1 co-infectionMedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-003067-30-DEBristol-Myers Squibb International Corporation500
进行中（未招募）
不适用
Safety and Efficacy study of BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in untreated Hepatitis C Patients Coinfected with HIV VirusChronic Hepatitis C / HIV-1 co-infectionMedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-003067-30-BEBristol-Myers Squibb International Corporation500