Recurrence of hepatitis C post-liver transplantation in patients with hepatitic C. MedDRA version: 14.1 Level: LLT Classification code 10070678 Term: Hepatitis C recurrent System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Advagraf
Product Name: tacrolimus
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration t
Sponsors
Dra Itxarone Bilbao. Servicio de cirugía hepatobiliopancreatica y trasplantes. HUVH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients ? 18 years with HCV RNA-positive 12 months before transplantation, recipients of a first orthotopic liver transplantation. 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Multi-organ transplant recipients or who have previously received an organ transplant. 2. Patients with split or living donor recipients. 3. Transplant recipients with ABO incompatibility. 4. Patients seropositive for HIV antibodies. 5. Recipients who receive a transplant for fulminant hepatic failure. 6. HCV patients with cirrhosis who received antiviral treatment before transplantation, and have to negative serum HCV-RNA. 7. Patients with known malignancy or history of malignancy except basal cell skin carcinoma and hepatocellular carcinoma meeting the following criteria: absence of vascular invasion, lymph single or less than two inches in diameter or two or three nodules of no more than three inches in diameter (Milan criteria). 8. Patients with a glomerular filtration <60 ml/min/1.73m 2 before transplantation or requiring renal dialysis before transplantation. 9. Patients in whom severe coexisting disease, or suffering any unstable medical condition that could affect the objectives of the study. 10. Patients who have been treated during the month prior to inclusion in the study with a drug or therapy is not recorded (investigational drug) or if such therapy be administered in the post-transplant. 11. Pregnant patients, nursing or of childbearing potential, not using effective contraception. Exclusion criteria at the time of randomization (day 28 post-transplant): Patients who have not completed the healing process post-transplant month. Patients with a platelet count <50.000/mm3, a WBC count <2000/mm3, active infection requiring ICU admission or threatens vital, requiring intensive care and life support measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the evolution of hepatitis C recurrence as determined by progression of liver fibrosis (F ? 2, as ranked by ISHAK) a year post-liver transplantation in patients receiving low dose tacrolimus in combination with mycophenolate mofetil vs everolimus.;Secondary Objective: 1. To assess the viral load of HCV RNA. 2. To characterize the haplotype of each patient. 3. Rate serological markers of hepatic fibrosis 4. To assess the elasticity of the liver parenchyma by FibroScan. 5. To compare the incidence of acute rejection and acute rejection corticoresistente. 6. Compare the time to first acute rejection episode. 7. Compare the need for antiviral therapy post-transplant year. 8. Assess patient survival and graft survival post-transplant year. 9. To evaluate the incidence of patient withdrawals or study discontinuation post-transplant year. 10. To evaluate the incidence of cardiovascular risk factors.;Primary end point(s): Percentage of patients with fibrosis grade ? 2 according to the classification of ISHAK;Timepoint(s) of evaluation of this end point: 12 months after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of biopsy-proven acute rejection. Time to first episode of acute rejection. Time to histologic recurrence of hepatitis C after liver transplantation. Measures of central tendency and viral load of HCV. Patient survival and graft. Incidence of adverse events.;Timepoint(s) of evaluation of this end point: 12 months after transplantation. | — |
Countries
Spain
Contacts
Public ContactDra Itxarone Bilbao
Servicio de cirugía hepatobiliopancreatica y trasplantes. HUVH
Outcome results
None listed