Intravenous Silimaryn in hepatitis C Liver Trasplantatio

Conditions: Patients transplanted for chronic liver disease or hepatocarcinoma relating to C virus being replicated at the time of the OLT (orthotopic liver transplantation).
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-001457-50-ES

Lead Sponsor: fUNDACIÓN iNVESTIGACIÓN HOSPITAL RAMÓN Y CAJA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.