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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381432
• Other study ID #: 112314
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: May 9, 2013
• Start date: December 2004
• Est. completion date: May 2011

Study information

• Verified date: May 2013
• 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 study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events related to azathioprine tablets		3 years	Yes