A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection (PEARL-I).

ABBOTT GMBH & Co. KG0 个研究点目标入组 160 人开始时间: 2012年11月23日最近更新: 2015年11月16日

适应症

试验速览

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•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: • Treatment-naïve: Subject has never received antiviral treatment for hepatitis C infection; •Prior null responders: Subject has documentation that they previously received pegIFN plus RBV for at least 10 weeks and failed to achieve a 2 log10 IU/mL HCV RNA decrease by Week 12 (Week 10 to Week 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 screening. 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: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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.

发起方