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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 23, 2011
Last updated: May 9, 2013
Last verified: May 2013
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

Condition Intervention
Liver Diseases
Drug: Azathioprine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of adverse events related to azathioprine tablets [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: December 2004
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed azathioprine tablet
Subjects prescribed azathioprine tablet during study period after the lung transplantation
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381432

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381432     History of Changes
Other Study ID Numbers: 112314 
Study First Received: June 23, 2011
Last Updated: May 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016