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

Completed

• Conditions: Liver Diseases
• Interventions: Drug: Azathioprine

• Registration Number: NCT01381432
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & 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 lung transplantation

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events related to azathioprine tablets	3 years