HCV recurrence in stable liver transplanted patients not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care,SOC) MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Legalon-SIL
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Silibinin-C-2’,3-dihydrogen succinate, disodium salt
CAS Number: 55254-34-7
Current Sponsor code: 345
Sponsors
ROTTAPHARM S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with HCV recurrent chronic hepatitis after liver transplantation, not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care, SOC). - Stable (= 1 year) liver transplanted patients with HCV recurrence (as indicated by positive serum HCV-RNA, increase in transaminases, signs of graft damage according to HCV recurrence and/or presence of liver fibrosis as assessed by Fibroscan). - Patients without biochemical, clinical and/or histological suspicion of rejection. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: - Patients with active hepatocellular carcinoma or other neoplasia. - Patients with active biliary tract anomalies. - Patients with a rejection episode in the 6 months preceding study inclusion. - Patients on active interferon treatment. - Patients with creatinine clearance < 50 ml.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment.;Secondary Objective: - To determine the effect of post-transplant treatment with Legalon SIL on lymphocyte activation during Short- and Long-Term follow up and HCV viral load one year after the beginning of treatment. - To determine the effect of post-transplant treatment with Legalon SIL on fibrosis and functional state. - To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators.;Primary end point(s): - HCV RNA at 30 days (end of the Short Term Follow-up);Timepoint(s) of evaluation of this end point: at 30 days after the beginning of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - at 30 days after the beginning of study treatment - at 1 year after the beginning of study treatment;Secondary end point(s): - To determine the effect of post-transplant treatment with Legalon SIL on lymphocyte activation during Short- and Long-Term follow-up. - to determine the effect of post-transplant Legalon SIL on liver fibrosis, liver functional state, and HCV viral load one year after the beginning of treatment. - To determine the safety and tolerability of post-transplant treatment with Legalon SIL, including evaluation of its effect on the levels of immunomodulators. | — |
Countries
Italy
Contacts
Public ContactDirezione scientifica
ROTTAPHARM S.P.A.
Outcome results
None listed