Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
This study has been completed.
Information provided by (Responsible Party):
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)|
Resource links provided by NLM:
U.S. FDA Resources
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 ]
|Study Start Date:||December 2004|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Subjects prescribed azathioprine tablet
Subjects prescribed azathioprine tablet during study period after the lung transplantation
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.
Contacts and Locations