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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381432
First received: June 23, 2011
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.

  Eligibility

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.
Criteria

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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

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:
Antirejection

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

ClinicalTrials.gov processed this record on September 18, 2014