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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381432
First Posted: June 27, 2011
Last Update Posted: May 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381432


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381432     History of Changes
Other Study ID Numbers: 112314
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
Antirejection

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