Personal monitoring of liver transplant patients infected with Hepatitis C Virus. Pilot study to compare the evolution of Hepatitis C by receiving immunosuppression with tacrolimus in combination with Mycophenolate Mofetil or Everolimus.

Phase 1

• Conditions: Recurrence of hepatitis C post-liver transplantation in patients with hepatitic C.; MedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 14.1Level: LLTClassification code 10070678Term: Hepatitis C recurrentSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2012-002105-22-ES
• Lead Sponsor: Dra Itxarone Bilbao. Servicio de cirugía hepatobiliopancreatica y trasplantes. HUVH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-25
• Study Completion: 2020-09-01
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified