ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 342 for:    liver transplant | Recruiting, Not yet recruiting, Available Studies

Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03140462
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus blood concentration in liver transplant recipients.

Condition or disease
Liver Transplantation

Detailed Description:
This study will start with a retrospective data analysis. The investigators will use the electronic databases of National Taiwan University Hospital to identify patients who underwent liver transplantation, received tacrolimus and were still followed up at the outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate participants, and find their donors. And analyze the effect of genetic polymorphism (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose normalized trough concentration of tacrolimus.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism of Donor on Tacrolimus Blood Concentration in Liver Transplant Patients
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Group/Cohort
liver transplant patients and donors
To study clinical and genetic factors on tacrolimus dose normalized trough concentration.



Primary Outcome Measures :
  1. Dose normalized trough concentration of tacrolimus in liver transplant patients within the first 6 months post-transplantation [ Time Frame: Within the first 6 months post-transplantation ]
    Analyse the effect of the donor's genetic polymorphism to dose normalized trough concentration of tacrolimus in liver transplant patients. Trough level of tacrolimus was adjusted by liver recipient's body weight.


Biospecimen Retention:   Samples With DNA
whole blood , paraffin-embedded liver biopsy, or saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver transplant patients' donors
Criteria

Inclusion Criteria:donors' recipients

  • Living liver transplant during 20070101 ~ 20151231 and only received liver transplantation
  • Lab data at least 8 months,
  • Receiving tacrolimus as immunosuppressive drugs
  • Transplantation at 20 ~ 65 years old

Exclusion Criteria: donors' recipients

  • Retransplantation or multi-organ transplantation
  • Non-Asian
  • Positive for human immunodeficiency virus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140462


Contacts
Contact: Fe-Lin Lin Wu +886-2-3366 8784 flwu@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Contact: Rey-Heng Hu         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Rey-Heng Hu National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03140462     History of Changes
Other Study ID Numbers: 201612023RIND
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Taiwan University Hospital:
Tacrolimus
Pharmacokinetics
Genetic polymorphisms

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action