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Completed

NCT Number: NCT01444079

Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Liver is an organ that is well-known for its immune tolerant capacity. However, there were still controversial issues about the impact of immunologic challenge after liver transplantation on the graft function. Different results of graft function affected by immunologic factors such as pre-transplant panel reactive antibody (PRA) status, pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor specific antibody (DSA) has been reported according to individual institutes. There was no trial for presenting anti-donor lymphocyte antibody change after liver transplantation.

The investigators designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the investigators will find aspects of anti-donor lymphocyte antibody change after liver transplantation.

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Key information

Conditions

Liver Transplant Rejection Behavior Rejection, Psychology Social Behavior

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

Study Design: Target study population is forty patients who will undergo liver transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded. Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3 month and 6 month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
  • Patients who can be followed for more than 3 months after transplantation

Exclusion criteria

  • Age under 20 years
  • Multi-organ transplantation
  • Not agree with informed consent
  • Patient who had plant to be transferred to other country or center

Treatment and study plan

Primary outcomes

  1. incidence of acute rejection

    Time frame: Time point when patients are diagnosed acute rejection

    We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.

Secondary outcomes

  1. correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival

    Time frame: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation

    We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2011
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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