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

Completed

• Conditions: Liver Diseases
• Interventions: Drug: Azathioprine

• Registration Number: NCT01390766
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed azathioprine tablet	Azathioprine	Subjects prescribed azathioprine tablet during study period after the liver transplantation

Primary Outcome Measures

Name	Time	Method
The number of incidence of adverse events related to azathioprine tablets and serious adverse events	1 year