An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritabprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 60 人开始时间: 2014年7月28日最近更新: 2017年10月2日

试验速览

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•1. Male or female at least 18 years of age at time of Screening.
•2. HCV GT1 or GT4 infection defined as: Positive for anti-HCV Ab, HCV RNA >1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening.
•3. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (ie CT or MRI).
•4. Child-Pugh Score 7-9 inclusive at time of 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 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Women who are pregnant or breastfeeding.
•2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) with positive Western blot.
•3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegIFN/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir)
•4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).
•5. Any current or past evidence of Child-Pugh C classification

发起方