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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390766
• Other study ID #: 112305
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: August 30, 2012
• Start date: August 2002
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Drug:
• Azathioprine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidence of adverse events related to azathioprine tablets and serious adverse events		1 year	Yes