EUCTR2011-002793-23-ES进行中（未招募）1 期
A Phase 3 Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects with Chronic Hepatitis C Genotype 4Revised Protocol 01, incorporating Protocol Amendment 03.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 152
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
- •? Subjects chronically infected with HCV Genotype 4
- •? HCV RNA viral load of ? 10,000 IU/mL
- •? No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent (DAA).
- •? Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted.
- •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 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •? Evidence of decompensated liver disease
- •? Documented or suspected HCC
- •? Positive for HBsAg or HIV-1/HIV-2 antibody at screening
研究者
相似试验
进行中（未招募）
不适用
Study in Genotype 1 and 4 Subjects with Chronic Hepatitis C, evaluating BMS-790052 in combination with Peg-Interferon Alfa-2a and RibaviriChronic Hepatitis CMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002793-23-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO557
进行中（未招募）
不适用
Study in Genotype 4 Subjects with Chronic Hepatitis C, evaluating BMS-790052 in combination with Peg-Interferon Alfa-2a and RibaviriChronic Hepatitis CMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-002793-23-GRBristol-Myers Squibb International Corporation172
进行中（未招募）
1 期
A Phase 2a Study of BMS-790052 in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects with Chronic Hepatitis C Virus Genotype 1 InfectioEUCTR2009-010149-29-FRBristol-Myers Squibb International Corporation65
进行中（未招募）
不适用
Study of BMS-790052 Add-On to Standard of Care in Treatment Naive SubjectsChronic Hepatitis CMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-018295-24-DKBristol Myers Squibb International Corporation625
进行中（未招募）
不适用
Study of BMS-790052 Add-On to Standard of Care in Treatment NaiveSubjectsEUCTR2010-018295-24-SEBristol-Myers Squibb International Corporation625