Last updated: 11/07/2018 04:40:18
Drug Use Investigation for IMURAN (azathioprine) Tablet (hepatic transplantation)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for IMURAN (azathioprine) Tablet (hepatic transplantation)
Trial description: This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidence of adverse events related to azathioprine tablets and serious adverse events
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Azathioprine
Enrollment:
41
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Ichiro Kumegawa, Norikazu Watanabe, Yusuke Inoue, Terufumi Hara, Pascal Yoshida . Drug Use Investigation of Azathioprine (Imuran®) Tablet in Patients undergoing Hepatic Transplantation . J Clin Therapeut Med. 2013;29(3):245-258.
Medical condition
Liver Diseases
Product
azathioprine
Collaborators
Not applicable
Study date(s)
August 2002 to May 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
None
- Subjects who undergo liver transplantation and azathioprine tablet was administered
- As this is PMS study, there are no exclusion criteria but contraindications are as follows.
- Subjects with hypersensitivity to the ingredients of azathioprine tablet
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who undergo liver transplantation and azathioprine tablet was administered
Exclusion criteria:
- As this is PMS study, there are no exclusion criteria but contraindications are as follows.
- 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
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-31-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website