Liver DiseasesNCT01390766

Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

An observational study of Liver Diseases, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Liver Diseases
What is being tested?: Azathioprine
Type of treatment: Pill or oral medicine
How many people: 41 participants
Where: No sites listed yet
Study dates: Aug 2002to May 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

Study population: The following subjects to whom azathioprine tablet is administered for "the suppression of liver transplant rejection"; * Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010. * Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.

Who may be able to join

Subjects who undergo liver transplantation and azathioprine tablet was administered

Who cannot join

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

About this study

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.

Conditions: Liver Diseases
Being tested: Azathioprine
Keywords: Antirejection
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzathioprineDrug

Study groups in NCT01390766
Study group	Role	What they receive
Subjects prescribed azathioprine tablet		Subjects prescribed azathioprine tablet during study period after the liver transplantation Receives: Drug: Azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

The number of incidence of adverse events related to azathioprine tablets and serious adverse events
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2002May 2011

First posted11 Jul 2011 (estimated)
Study startAug 2002
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Liver DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01390766
Sponsor's protocol ID: 112305
Status last verified: Aug 2012
First submitted: 23 Jun 2011
Last updated: 3 Sep 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B

All Liver Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)
ClinicalTrials.gov ID: NCT01390766
Acronym / sponsor ID: 112305
Conditions: Liver Diseases
Keywords: Antirejection
Study type: Observational
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2002
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 11 Jul 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects prescribed azathioprine tablet	–	Drug: AzathioprineSubjects prescribed azathioprine tablet during study period after the liver transplantation

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
Study population: The following subjects to whom azathioprine tablet is administered for "the suppression of liver transplant rejection"; * Subjects on whom liver transplantation is performed and to whom azathioprine tablet is administered within 1 year after transplant surgery from the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) to May 2010. * Subjects on whom liver transplantation is performed before the approval date of the additional indication of azathioprine tablet for liver transplantation (20 June 2001) and to whom azathioprine tablet is administered within 1 year after transplant surgery.

Key inclusion criteria (1 listed)

Subjects who undergo liver transplantation and azathioprine tablet was administered

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azathioprine	Drug	Subjects prescribed azathioprine tablet

Primary outcome

The number of incidence of adverse events related to azathioprine tablets and serious adverse events
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.

Related trials for Liver Diseases

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Diseases, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of incidence of adverse events related to azathioprine tablets and serious adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01390766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.