Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

May 9, 2013 updated by: GlaxoSmithKline
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

  1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010.
  2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.

Description

Inclusion Criteria:

  • Subjects who undergo lung transplantation and azathioprine tablets were administered

Exclusion Criteria:

  • 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 lung transplantation
Drug: Azathioprine
At the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events related to azathioprine tablets
Time Frame: 3 years
3 years

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

December 1, 2004

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

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112314

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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