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Randomised controlled trial of total immunosuppression withdrawal in liver transplant recipients: role of ursodeoxycholic acid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16781831
Enrollment
46
Registered
2007-03-28
Start date
1995-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Liver transplantation, rejection, withdrawal of immunosuppressions Injury, Occupational Diseases, Poisoning Failure and rejection of transplanted organs and tissues

Interventions

26 liver recipients who had been free of rejection while on immunosuppressive agents for a minimum of two years will be randomised to receive either 15 mg/kg of ursodeoxycholic acid (UDCA) (N = 14) or

Sponsors

University of Western Ontario (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Recipients of liver transplantation at the University of Western Ontario, Canada who had stable graft function (no clinical or biochemical evidence of liver disease) for a minimum of two years were offered TIW if they met the following criteria: 1. No documented rejection episodes for at least 24 months prior to the study 2. A minimum post-transplant follow up period of at least 2 years 3. A history of compliance with medications, blood testing for laboratory analyses and in the case of patients transplanted for alcohol-induced liver disease, abstinence from all alcohol beverages during the study period

Exclusion criteria

Exclusion criteria: 1. Patients requiring triple anti-rejection therapy for frequent or severe episodes of rejection in the past 2. More than one liver transplant 3. Requiring anti rejection therapy for non-liver disorders (psoriasis, rheumatoid arthritis [RA] etc)

Design outcomes

Primary

MeasureTime frame
1. Biochemical and histological evidence of rejection 2. Graft dysfunction without rejection 3. Recurrence of pre-transplant disease 4. Six months without immunosuppression and no rejection or dysfunction on repeat liver biopsy

Secondary

MeasureTime frame
1. Development of renal failure 2. Hypertension 3. Extent of liver enzymes abnormalities 4. Safety and compliance

Countries

Canada

Outcome results

None listed

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