HCV infection and liver trasplant MedDRA version: 19.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848 MedDRA version: 19.0 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Zepatier (Tablets: 50 mg elbasvir and 100 mg grazoprevir)
Product Name: zepatier tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Elbasvir
Other descriptive name: ELBASVIR
Concentr
Sponsors
Fundació clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 78 year-old. - Previous liver transplantation (more than 6 months). - Genotype 1 and 4 infection. - Hepatitis C recurrence defined by the presence of abnormal liver function tests, positive HCV-RNA, histological signs of hepatitis C recurrence. - Viral load = 10000 UI/mL. - Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, =10mg/d). - Treatment naïve or treatment experienced (Peg-RBV or triple therapy) 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Genotype 2, 3, 5 or 6 infection. - Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C. - Hepatocellular carcinoma after liver transplantation. - Total bilirubin > 3 mg/dL. - Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus). - Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes. - Platelets < 75 x 109 cells/L. - Neutrophil count < 0.5 x 109 cells/L. - Hemoglobin < 9 g/dL. - Albumin < 3g/dL. - HIV infection. - Hepatitis B infection. - Active intake of toxic amounts of alcohol or recreational drugs. - Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding. - Intake of disallowed medications including(but not limited to): 1. Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin 2. Antifungals: itraconazole, ketoconazole, voriconazole 3. Antihypertensives: nifedipine 4. Anticonvulsants: carbamazepine, phenytoin, phenobarbital 5. Bosentan 6. Modafinil 7. St.Jonh’s Wort 8. Immunosuppressants: cyclosporin, everolimus, sirolimus 9. Diabetes agents: glibenclamide, glyburide 10. Lipid lowering agents: gemfibrozil 11. Eltrombopag 12. Lapatinib 13. HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors 14. Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and tolerability of Grazoprevir and Elbasvir in liver transplant recipients with hepatitis C recurrence.;Secondary Objective: - To evaluate the beneficial effect of antiviral therapy in liver function. - To assess the impact of therapy in kidney function.;Primary end point(s): 6.2. Primary end point: Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment week 12.;Timepoint(s) of evaluation of this end point: Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the beneficial effect of antiviral therapy in liver function. - To assess the impact of therapy in kidney function.;Timepoint(s) of evaluation of this end point: - Sustained virological response 4 (SVR4) and 24 (SVR24) defined as HCV-RNA undetectable at post-treatment weeks 4 and 24, respectively. - Effects of antiviral therapy on renal function.(cleareance de creatinine) - Effects of antiviral therapy in liver function.(transaminases) - Tolerability of this combination in liver transplant recipients. | — |
Countries
Spain
Contacts
Public ContactCTU Clinic-Farmacologia Clinica
CTU Clinic. Hospital clinic de Barcelona
Outcome results
None listed