Glecaprevir/ pibrentasvir plus fixed-dose combination for 6 weeks in patients with acute hepatitis C virus: a pilot study. - Six weeks of Glecaprevir/ pibrentasvir for patients with acute HCV infection.

AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO0 个研究点目标入组 50 人开始时间: 2020年11月4日最近更新: 2021年8月17日

适应症

试验速览

暂无简介。

•Inclusion Criteria will be:
•-Adult patients (=18 years);
•-Presenting acute HCV infection (all genotypes);
•-With or without HIV co-infection;
•-Active or inactive drug users
•Diagnosis of AHC:
•Acute HCV infection was defined as either a documented seroconversion to HCV antibody positivity within the 4 months before screening, or known or suspected exposure to HCV within the 4 months before
•screening with raised alanine aminotransferase concentration more than ten times the upper limit of
•normal at screening or within a 4-week period before 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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•-Patients fulfilling the criteria for acute liver failure (evidence of coagulation abnormality, INR > 1.5, and any degree of encephalopathy) (6).
•-HBV co-infection;
•-Patients with previous HCV infection cured by DAA regimens who were reinfected after HCV clearance
•-Patients with chronic liver disease of any other etiology (NASH, ASH, autoimmune, metabolic);
•-Concomitant use with atazanavir and rifampicin;
•-Hypersensitivity to the active substances or to any of the excipients;
•-Pregnancy.

发起方

AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO