Status:
NOT_YET_RECRUITING
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good eff...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 years old and above
- 3 months after liver transplantation;
- Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
- The serum levels of aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] were within the normal range; ….
- Exclusion Criteria
- Multi-organ combined transplantation or multiple liver transplantation;
- Multiple organ recipients or those who have previously transplanted any organs；
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
- Participation in any other clinical study within 3 months prior to enrollment;
- Use of tacrolimus sustained release capsules before enrollment;
- Tacrolimus trough concentration lower than 5 ng/ml at the time of screening;
- Acute rejection occurred within one month prior to enrollment; ….
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06147648
Start Date
December 1 2023
End Date
July 30 2026
Last Update
November 27 2023
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