EUCTR2012-003088-23-FR进行中（未招募）1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 381
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
入选标准
- •-Males or females 18 - 70 years old, inclusive
- •-Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
- •-Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening
- •-Subject has either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond
- •-Documentation of cirrhosis (Child Pugh A)
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •-Positive screen for drugs or alcohol
- •-Significant sensitivity to any drug
- •-Use of contraindicated medications within 2 weeks of dosing
- •-Abnormal laboratory tests
- •-Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and CirrhosisHepatitis C InfectionMedDRA version: 17.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-001496-31-ATAbbVie Deutschland GmbH & Co. KG160
进行中（未招募）
1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Cirrhosis (AGATE-I)Hepatitis C InfectionMedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-001496-31-BEAbbVie Deutschland GmbH & Co. KG190
进行中（未招募）
不适用
A randomized, open-label study to evaluate the safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in people with Genotype 1 hepatitis C Virus (HCV) and early liver damage. Experimental means that they have not been approved by any regulatory agency for sale to the public.EUCTR2012-003088-23-BEAbbVie Deutschland GmbH & Co. KG381
进行中（未招募）
1 期
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Cirrhosis (AGATE-I)EUCTR2014-001496-31-DEAbbVie Deutschland GmbH & Co. KG190
进行中（未招募）
1 期
A randomized, open-label study to evaluate the safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in people with Genotype 1 hepatitis C Virus (HCV) and early liver damage. Experimental means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C Infection and compensated cirrhosisMedDRA version: 17.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2012-003088-23-GBAbbott GmbH & Co. KG381