EUCTR2011-005762-38-ES进行中（未招募）不适用
A Randomized, Open-Label Study to Evaluate theSafety and Efficacy of Coadministration of ABT-450with Ritonavir (ABT-450/r) and ABT-267 in Adultswith Chronic Hepatitis C Virus Infection (PEARL-I)
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
- 200
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 between the age of 18 and 70 years, inclusive, at time of enrollment.
- •2.Subjects must meet one of the following categories:
- •?Never received antiviral treatment for hepatitis C infection;
- •?Documented null-response (received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failure to achieve a 2 log10 IU/ml reduction in HCV RNA at week 12 (Week 10-16).
- •3.Body mass index (BMI) is ? 18 to < 38 kg/m2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
- •4.Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
- •5.Subject has plasma HCV RNA level > 10,000 IU/mL at 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.History of severe, life-threatening or other significant sensitivity to any drug.
- •2.Females who are pregnant or breastfeeding.
- •3.Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
- •4.Positive test result for hepatitis B surface antigen or anti-HIV antibodies.
- •5.Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
研究者
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