This non-interventional observational study (CRAD001H2406) is to evaluate recurrence of hepatocellular carcinoma (HCC) until Month 60 post-transplantation in liver transplant recipients with primary HCC at liver transplantatio
Phase 4
- Conditions
- Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis
- Registration Number
- CTRI/2019/10/021760
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
1. Patients who have completed 24 month RCT study CRAD001H2307 and had primary HCC at the time of liver transplantation.
2. Patient who signed the informed consent to participate in this NIS.
Exclusion Criteria
1. Patient with a liver graft loss during the 2 years in the CRAD001H2307 study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in <br/ ><br>combination with reduced TAC compared to standard TAC (Control) in LDLTRs with <br/ ><br>primary HCC at liver transplantation.Timepoint: To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in <br/ ><br>combination with reduced TAC compared to standard TAC (Control) in LDLTRs with <br/ ><br>primary HCC at liver transplantation.
- Secondary Outcome Measures
Name Time Method To evaluate the 60 months outcomes in relation to rejections, graft loss, death, <br/ ><br>immunosuppressive regimen, concomitant medication, changes in renal function, other <br/ ><br>malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced <br/ ><br>TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver <br/ ><br>transplantation.Timepoint: To evaluate the 60 months outcomes in relation to rejections, graft loss, death, <br/ ><br>immunosuppressive regimen, concomitant medication, changes in renal function, other <br/ ><br>malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced <br/ ><br>TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver <br/ ><br>transplantation.