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

NCT01381432 | Completed

• 1 other identifier: 112314
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Diseases

Keywords

Antirejection

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events related to azathioprine tablets

  3 years

Study Arms (1)

Subjects prescribed azathioprine tablet

Subjects prescribed azathioprine tablet during study period after the lung transplantation

Drug: Azathioprine

Interventions

Azathioprine DRUG

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.

Subjects prescribed azathioprine tablet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• 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 lung transplant rejection"; 1. Subjects on whom lung transplantation is performed after approval and to whom azathioprine tablet is administered from transplant surgery to May 2010. 2. Subjects on whom lung transplantation is performed before approval and who have already completed the drug administeration as well as during the drug administration at the time of the contract terminiation.

You may qualify if:

• Subjects who undergo lung transplantation and azathioprine tablets were 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: June 27, 2011
• Study Start: December 1, 2004
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 13, 2013

Record last verified: 2013-05