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

NCT01390766 | Completed

• 1 other identifier: 112305
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Diseases

Keywords

Antirejection

Outcome Measures

Primary Outcomes (1)

• The number of incidence of adverse events related to azathioprine tablets and serious adverse events

  1 year

Study Arms (1)

Subjects prescribed azathioprine tablet

Subjects prescribed azathioprine tablet during study period after the liver transplantation

Drug: Azathioprine

Interventions

Azathioprine DRUG

Subjects prescribed azathioprine tablet

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The following subjects to whom azathioprine tablet is administered for "the suppression of liver transplant rejection"; * Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010. * Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.

You may qualify if:

• Subjects who undergo liver transplantation and azathioprine tablet was administered

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Liver Diseases

Interventions

Azathioprine

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 11, 2011
• Study Start: August 1, 2002
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 3, 2012

Record last verified: 2012-08