Budesonide versus prednisolone after liver transplantation: a phase 3, open label, non-inferiority randomised controlled trial

Phase 3

Recruiting

• Conditions: iver transplantation; Allograft rejection; Liver transplantation; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery

• Registration Number: ACTRN12623000340639
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-31
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All adult (age 18 years or over) patients accepted for liver transplantation at Austin Health.

Exclusion Criteria

- Strong medical rationale for a corticosteroid-free protocol (e.g. severe psychiatric comorbidities, high risk of infection) as determined by the Liver Transplant Multidisciplinary Team

- Patient with autoimmune hepatitis

- Corticosteroid dependency prior to trial enrolment

- Patients receiving multi-visceral organ transplantation

- Previous liver transplant recipient requiring redo liver transplant

- Portosystemic shunt >15mm in diameter on imaging which will reduce budesonide first pass metabolism

- Concurrent use of medications that are significant cytochrome P450 3A4 inhibitors (e.g. erythromycin, clarithromycin, verapamil, diltiazem) which will reduce budesonide first pass metabolism

- Unable to take medications enterally (either orally or through tube feeding) by day 3 post liver transplant

- Patients unable to understand written English sufficiently to read PICF or have no carer to assist them with adequate understanding of PICF

Study & Design

• Study Type: Interventional
• Study Design: Not specified