Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

August 30, 2012 updated by: GlaxoSmithKline
This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The following subjects to whom azathioprine tablet is administered for "the suppression of liver transplant rejection";

  • Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010.
  • Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.

Description

Inclusion Criteria:

  • Subjects who undergo liver transplantation and azathioprine tablet was administered

Exclusion Criteria:

As this is PMS study, there are no exclusion criteria but contraindications are as follows.

  • Subjects with hypersensitivity to the ingredients of azathioprine tablet
  • Subjects who is pregnant or might be pregnant
  • Subjects whose white count is lower than 3000/cubic millimeter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects prescribed azathioprine tablet
Subjects prescribed azathioprine tablet during study period after the liver transplantation
Drug: Azathioprine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of incidence of adverse events related to azathioprine tablets and serious adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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