Patients transplanted for chronic liver disease or hepatocarcinoma relating to C virus being replicated at the time of the OLT (orthotopic liver transplantation).
Conditions
Interventions
Trade Name: Legalon SIL
Product Name: LEGALON SIL
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Legalon SIL
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Sponsors
fUNDACIÓN iNVESTIGACIÓN HOSPITAL RAMÓN Y CAJAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients having receivesd written property information about the study design, endpoints and possible risks and they are able to refuse their consent at any time, give their consent to participate and supply of samples for celular and molecular studies Patients infected with the virus of hepatitis C. HCV-positive candidates in whom who the indication of liver transplantation is one of the globally accepted (hepatocellular and/or a HCC and/or alcohol failure). Women of childbearing potential must have a negative pregnancy test at screening visit. Futher agree to use adequate contraception (including double barrier as condoms plus diaphrams, or surgical sterilization) whitin 30 days after administration of study drug. 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 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Refusal of informed consent. Contraindication for liver transplantation. Patient undergoing multiple organ transplantation. Hepatitis B virus-coinfected patient. Pregnacy or planning to become pregnant during the study. Lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study if treatment with intravenous Silymarin during perioperative OLT prevents graft infection and hepatitis virus C recurrence, in positive HCV patients.;Timepoint(s) of evaluation of this end point: DAY 1, 3, 5, 7 and 14 post liver tranplantation. If Negative RNA on day 14: 21, 28, 32, 42 and 49 days;Secondary Objective: Study the antiviral effect of intravenous Silymarin during perioperative OLT period on hepatitis C virus in positive HCV patients transplanted liver in the pattern used in our study. Determine if there is a relationship between IL-28 polymorphisms and response to treatment. Studying possible mutations in the virus-polymerase secondary to use of Silymarin.;Primary end point(s): HCV RNA: We will determinate IT before anaesthetic induction, anhepatic phase, every 6 hours in 24 hours after OLT and on days 1, 3, 5, 7 and 14 after OLT. If RNA becomes negative, it should be determined on the 21, 28, 35, 42 Y 49 days, the third month and 6 months to demonstrate VSR. If HCV fails to reach clearance viral load determinations will taken on 21 and 28 days after OLT and thereafter according to clinical protocol. Shall be considered as infection (SVR) has been avoided if the patient remains undetectable HCV RNA at least 6 months after completion of treatment with Silymarin and in the absence of other treatments for hepatitis C infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Patients will be evaluated daily by one of the clinical cares participants in the study in order to assess the occurrence of possible side or adverse effects of treatment. A physical examination and appropriate anamnesis will be perform and determined daily or every 48 hours values of creatinine, transaminases, bilirubin, GGT and FA, hemoglobin, hematocrit, platelet and leukocytes count, prothrombin, activity time cefalina and INR, as well as monitoring of blood levels of immunosuppressants (those which use monitoring) and other analytical determinations considered necessary. - DNA-CMV will be determinate according to each centre protocol and the histological results of biopsies made by protocol or indication will be shown in the final data. - IL-28 polymorphisms, both donor and recipient, as well as the possible occurrence of HCV polymerase-mutations will be determined during the duration of the study. -To determine the occurrence of resistant forms or the existence of basal resistant forms we will discuss in this region through RT-PCR and sequencing with BigDye viral RNA terminator v. 3.1 (Applied Biosistems) prior to treatment serum in subsequent samples in cases with signs of resurgence of viral load or not respondents.;Timepoint(s) of evaluation of this end point: DAY 1, 3, 5, 7 and 14 post liver tranplantation. If Negative RNA on day 14: 21, 28, 32, 42 and 49 days | — |
Countries
Spain
Contacts
Public ContactFundación Investigación
Fundación Investigación Biomédica Hospital Ramón y Cajal
Outcome results
None listed