Efficacy and safety of Glecaprevir/Pibrentasvir plus Ribavirin in Patients who failed Direct-acting antivirals; DAAs with chronic hepatitis C
- Conditions
- chronic hepatitis C
- Registration Number
- JPRN-UMIN000031615
- Lead Sponsor
- Tokai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Decompensated cirrhosis(jaundice,refractory ascites,hepatic encephalopathy,esophageal varices,spontaneous bacterial peritonitis) 2) Child-Pugh >6 at screening 3) Patients during treatment regardless of any type of cancer 4) Pregnancy or possible pregnancy and breast feeding 5) Patients with severe heart disease 6) Patients with haemoglobinopathies 7) The patients who meets even one any of the following, neutrophils less than 750 /mm3, platelet counts less than <50000 /mm3, Hb less than 10 g/dl 8) Patients with impaired renal function with chronic kidney failure or creatinine clearance less than 50 ml/min 9) Patient with severe mental diseases such as severe depression, the suicide consideration 10)Patients who cannot keep 6-month contraception after in the dosage and the dosage in the male patients that a partner may become pregnant 11)Patients who was judged to be inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method