A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 343 人开始时间: 2017年6月1日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•1. Male or female, at least 18 years of age at time of Screening;
•2. Screening laboratory result indicating HCV GT 1, 2, 4, 5 or 6 infection;
•3. Positive plasma HCV antibody and HCV RNA viral load = 1000 IU/mL at Screening;
•4. Treatment-naïve to any approved or investigational anti-HCV medication;
•5. Subject must be documented as cirrhotic, with a Child-Pugh score of =6.
•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 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug;
•2. Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding, radiographic evidence of small ascites, or empiric use of lactulose/rifaximin. The use of beta blockers is not exclusionary;
•3. Current HBV or HIV infection on screening tests, defined as:
•A positive HBsAg, or;
•HBV DNA > LLOQ in subjects with isolated positive anti-HBc (i.e., negative HBsAg and Anti-HBs), or;
•A positive anti-human immunodeficiency virus antibody (HIV Ab).
•4. HCV genotype performed by the central laboratory during screening indicating genotype 3 infection or co-infection with more than one HCV genotype;
•5. Screening laboratory analyses showing any of the following abnormal laboratory results:
•Alanine aminotransferase ALT > 10 × ULN
•Aspartate aminotransferase AST > 10 × ULN
•Total Bilirubin > 3.0 mg/dL
•Calculated creatinine clearance (CrCl, Cockcroft-Gault method) of < 50 mL/min
•Albumin < 2.8 mg/dL
•Hemoglobin < 10 g/dL
•Platelets < 50,000 cells/mm3

发起方