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 transplantation

A long-term non-interventional observational study in Living Donor Liver Transplant Recipients (LDLTRs) with primary hepatocellular carcinoma (HCC) treated with Certican® / Zortress® (everolimus; EVR) plus reduced tacrolimus (rTAC) versus standard tacrolimus (sTAC) control

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/10/021760

Enrollment

Registered

2019-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K742- Hepatic fibrosis with hepatic sclerosis

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patient with a liver graft loss during the 2 years in the CRAD001H2307 study.

Design outcomes

Primary

Measure	Time frame
To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.Timepoint: To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.	—

Measure

Time frame

To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.Timepoint: To evaluate HCC recurrence until Month 60 post-transplantation with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.

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Secondary

Measure	Time frame
To evaluate the 60 months outcomes in relation to rejections, graft loss, death, immunosuppressive regimen, concomitant medication, changes in renal function, other malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.Timepoint: To evaluate the 60 months outcomes in relation to rejections, graft loss, death, immunosuppressive regimen, concomitant medication, changes in renal function, other malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.	—

Measure

Time frame

To evaluate the 60 months outcomes in relation to rejections, graft loss, death, immunosuppressive regimen, concomitant medication, changes in renal function, other malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.Timepoint: To evaluate the 60 months outcomes in relation to rejections, graft loss, death, immunosuppressive regimen, concomitant medication, changes in renal function, other malignancies than HCC and AEs/SAEs with everolimus (EVR) in combination with reduced TAC compared to standard TAC (Control) in LDLTRs with primary HCC at liver transplantation.

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Countries

Canada, Egypt, India, Italy, Japan, Republic of Korea, Saudi Arabia, Singapore, Turkey, United States of America

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results