TACROLIMUS – DACLIZUMAB - MYCOPHENOLATE MOFETIL IMMUNE PROPHYLAXIS IN PEDIATRIC LIVER TRANSPLANTATION. An open, pilot, investigator-driven study in 20 recipients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003023-20-BE

Enrollment

Registered

2008-06-13

Start date

2008-09-11

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

Liver transplantation MedDRA version: 9.1 Level: LLT Classification code 10024678 Term: Liver failure

Interventions

Trade Name: Prograft Pharmaceutical Form: Capsule* Trade Name: Cellcept Pharmaceutical Form: Coated tablet Trade Name: Zenapax Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * All liver transplantation indications, excluding hepatic malignancy, autoimmune hepatitis, and fulminant liver failure from unknown etiologies. * Recipient age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Retransplantation * Combined transplantation * Transplantation for hepatic malignancy * Transplantation for autoimmune disease * Fulminant hepatitis with autoimmune markers * Fulminant hepatitis of unknown etiology * Previous chronic steroid therapy (risk of post-transplant adrenal insufficiency) * Previous hepatocyte transplantation

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The initial objective of this pilot study being to assess the safety of tacrolimus – daclizumab – mycophenolate mofetil immune prophylaxis, the following endpoints will be considered: * Incidence of acute rejection at 3 and 12 months * Incidence of steroid resistant acute rejection at 3 and 12 months * Incidence of steroid dependence at 3 and 12 months * Incidence of chronic rejection at 12 months * Incidence of infection (bacterial, CMV, EBV) at 12 months * Incidence of EBV-related PTLD at 12 months ;Main Objective: The initial objective of this pilot study being to assess the safety of tacrolimus – daclizumab – mycophenolate mofetil immune prophylaxis, the following endpoints will be considered: * Incidence of acute rejection at 3 and 12 months * Incidence of steroid resistant acute rejection at 3 and 12 months * Incidence of steroid dependence at 3 and 12 months * Incidence of chronic rejection at 12 months * Incidence of infection (bacterial, CMV, EBV) at 12 months * Incidence of EBV-related PTLD at 12 months ;Secondary Objective: Other variables including 3-month and 1-year patient and graft survival, steroid-free survival, statural growth velocity, and kidney function, as estimated using the Schwartz formula, will also be recorded. This study will also include ELISPOT IFN gamma and Granzyme for the assessment of specific allogenic responsiveness of the recipient, the dosage of circulating cytokines (IL-10, IFN-?, IL-4, IL-6, TNF-a, Il-2) by cytometric bead array as well as the detection of regulatory T-cells by flow cytometry. Blood samples for these tests will be performed before the transplant, on day 7 post-LT and on 180 days post-LT. The goal of this immunologic monitoring protocol is to perform a better study of the rejection phenomenon when it occurs.	—

Measure

Time frame

Primary end point(s): The initial objective of this pilot study being to assess the safety of tacrolimus – daclizumab – mycophenolate mofetil immune prophylaxis, the following endpoints will be considered: * Incidence of acute rejection at 3 and 12 months * Incidence of steroid resistant acute rejection at 3 and 12 months * Incidence of steroid dependence at 3 and 12 months * Incidence of chronic rejection at 12 months * Incidence of infection (bacterial, CMV, EBV) at 12 months * Incidence of EBV-related PTLD at 12 months ;Main Objective: The initial objective of this pilot study being to assess the safety of tacrolimus – daclizumab – mycophenolate mofetil immune prophylaxis, the following endpoints will be considered: * Incidence of acute rejection at 3 and 12 months * Incidence of steroid resistant acute rejection at 3 and 12 months * Incidence of steroid dependence at 3 and 12 months * Incidence of chronic rejection at 12 months * Incidence of infection (bacterial, CMV, EBV) at 12 months * Incidence of EBV-related PTLD at 12 months ;Secondary Objective: Other variables including 3-month and 1-year patient and graft survival, steroid-free survival, statural growth velocity, and kidney function, as estimated using the Schwartz formula, will also be recorded. This study will also include ELISPOT IFN gamma and Granzyme for the assessment of specific allogenic responsiveness of the recipient, the dosage of circulating cytokines (IL-10, IFN-?, IL-4, IL-6, TNF-a, Il-2) by cytometric bead array as well as the detection of regulatory T-cells by flow cytometry. Blood samples for these tests will be performed before the transplant, on day 7 post-LT and on 180 days post-LT. The goal of this immunologic monitoring protocol is to perform a better study of the rejection phenomenon when it occurs.

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026