A Phase 2 interventional study of Silibinin (Legalon-SIL) and Saline in Hepatitis C Virus Recurrence, sponsored by Rottapharm. Terminated at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Rottapharm · Phase 2, Interventional, and Treatment
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
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Exclusion Criteria:
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)
Placebo (saline), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
Drug: Saline
20 mg/kg Silibinin (Legalon SIL), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
Also known as: Legalon-SIL, SHS
Placebo
Also known as: Placebo (saline), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days
Viral load
To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.
Time frame: 30 days after the beginning of treatment
Viral load and lymphocyte activation
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.
Time frame: 1 year after the beginning of the treatment
Fibrosis
To determine the effect of post-transplant treatment with Legalon SIL on fibrosis and functional state.
Time frame: 1 year after the beginning of the treatment
Safety
To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.
Time frame: 1 year
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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