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NCT03423225

To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

Completed Phase 4 Last updated 6 February 2018
What this trial tests

Phase 4 trial testing ADVAGRAF® in Liver Transplantation in 31 participants. Completed in 14 December 2017.

Timeline
22 March 2016
Primary endpoint
18 July 2017
14 December 2017

Quick facts

Lead sponsorKim, Seoung-Hoon
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposescreening
Enrollment31
Start date22 March 2016
Primary completion18 July 2017
Estimated completion14 December 2017

Drugs / interventions tested

Conditions studied

Sponsor

Kim, Seoung-Hoon

Who can join

20 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients. Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety and Efficacy of Once-Daily Prolonged-Release Tacrolimus in Living Donor Liver Transplantation: An Open-Label, Prospective, Single-Arm, Phase 4 Study.
    Lee EC, Kim SH, Park SJ. · · 2018 · cited 2× · PMID 30310047 · DOI 10.12659/aot.910618

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Other recruiting trials for Liver Transplantation

Currently open trials in the same condition.

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