Envarsus® will be compared with the current standard treatment Advagraf® after liver transplantation.

Phase 1

• Conditions: liver transplantation; MedDRA version: 20.0Level: PTClassification code 10024715Term: Liver transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002856-34-NL
• Lead Sponsor: Foundation for Liver research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• First liver transplantation
• Age between 18 and 75
• Using immediate release tacrolimus
• Female subjects of childbearing potential must agree to practice effective birth control during the study
• Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

• Pregnancy
• eGFR < 30 mL/min/1.73m2
• Systemic infection
• Combined organ transplantation
• Use of a mTOR inhibitor
• Use of other tacrolimus formulations
• Hepatic artery trombosis
• Known allergy to the study drug or any of its components

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified