EUCTR2012-003754-84-SK进行中（未招募）不适用
A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with and without Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon a-2a and Ribavirin in Treatment-Naïve Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
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
- 314
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
- •1. Male or female and age is between 18 and 65 years, inclusive, at time of Screening. Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
- •2. Subject has never received antiviral treatment for hepatitis C infection.
- •3. Chronic HCV Genotype-1 infection prior to study enrollment.
- •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 314
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
- •2. Positive screen for drugs or alcohol.
- •3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- •4. Females who are pregnant or plan to become pregnant, or breastfeeding
- •5. Any current or past clinical evidence of cirrhosis
- •6. Screening laboratory analyses that showing abnormal laboratory results
- •7. Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for Telaprevir, PegIFN and RBV
研究者
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