Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-28 @ 11:02 PM
Study NCT ID:
NCT01518933
Status:
TERMINATED
Last Update Posted:
2015-03-05
First Post:
2012-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients
Sponsor:
Rottapharm
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
when a blind review highlighted that at least 43% of patients had a virological response
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEG-SIL-LTX-02
Brief Summary:
Hepatitis C virus (HCV)-related liver disease is the most common indication for liver transplantation (LT). However, LT does not cure the infection, and therapeutic strategies 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: