Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients (LEG-SIL-LTX-02)
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|ClinicalTrials.gov Identifier: NCT01518933|
Recruitment Status : Terminated (when a blind review highlighted that at least 43% of patients had a virological response)
First Posted : January 26, 2012
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Recurrence||Drug: Silibinin (Legalon-SIL) Drug: Saline||Phase 2|
Hepatitis C virus (HCV)-related liver disease continues to be the most common indication for liver transplantation (LT) in both the United States and Europe. However, LT does not cure the infection, and re-infection of the liver allograft universally occurs. Recurrent HCV hepatitis often follows an accelerated course after LT, and histological recurrence occurs in approximately 50% of patients within 1 year after LT; 15-30% of them develop cirrhosis within 5 years. In this context, a peculiar feature is represented by the rapid course of liver fibrosis. Therapeutic strategies for managing the primary cause of liver damage, i.e. HCV infection, irrespective of application in pre-, peri-, and/or post-LT periods resulted in very limited efficacy and tolerability in LT recipients.
In view of its postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV recurrent patients after liver transplantation.
Silibinin, a flavonolignan representing the main component (60%) of Silymarin and proposed as an anti-hepatotoxic agent for the treatment of various liver diseases has been recently reported to beneficially modulate the pro-fibrogenic potential of HSC, thus representing a very attractive possibility in the transplanted population. Besides the anti-inflammatory properties, Silibinin is able to inhibit Tumor necrosis factor-alpha (TNF-α). This is a proinflammatory cytokine with a major role in both acute and chronic viral, bacterial and fungal infections.
The primary objective is to determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.
44 stable liver transplanted patients with HCV recurrence will be randomized 3:1 to receive Legalon-SIL or Placebo. Randomized patients will be treated for 14 consecutive days with Legalon-SIL or Placebo. Patients dropping-out before the end of treatment period will be replaced.
Patients will be followed up for 1 year to monitor the effect of treatment on liver fibrosis, liver functional state, lymphocyte activation, and viral load.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of LEGALON SIL for the Treatment of HCV Recurrence in Stable Liver Transplanted Patients|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Silibilin (Legalon-SIL)
20 mg/kg Silibinin (Legalon SIL) ,as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
Drug: Silibinin (Legalon-SIL)
20 mg/kg Silibinin (Legalon SIL), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
Placebo Comparator: Saline
Placebo (saline), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
Other Name: Placebo (saline), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days
- Viral load [ Time Frame: 30 days after the beginning of treatment ]To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.
- Viral load and lymphocyte activation [ Time Frame: 1 year after the beginning of the treatment ]To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load and lymphocyte activation one year after the beginning of treatment.
- Fibrosis [ Time Frame: 1 year after the beginning of the treatment ]To determine the effect of post-transplant treatment with Legalon SIL on fibrosis and functional state.
- Safety [ Time Frame: 1 year ]To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518933
|Azienda Ospedaliero-Universitaria Policlinico Consorziale|
|Bari, Italy, 70124|
|Principal Investigator:||Alfredo Di Leo, MD||Azienda Ospedaliero-Universitaria Policlinico Consorziale - Bari|