NCT00525473

Brief Summary

Azathioprine (AZA) has long been used in dermatology in treating autoimmune bullous dermatoses and generalized eczematous disorders as well as some photodermatoses. Its metabolic process inside human body and its side effects relies on genetic polymorphism of some enzymes such as thiopurine s-methyltransferase (TPMT) and inosine triphosphate pyrophosphatase gene (ITPA). This study aims to analyze the relative contribution of TMPT and ITPA mutations to the development of toxicity induced by AZA treatment and to detect the correlation of the genetic polymorphism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 17, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

September 3, 2007

Last Update Submit

May 16, 2012

Conditions

AzathioprineThiopurine MethyltransferaseInosine Triphosphate PyrophosphataseGenetic Polymorphism

Outcome Measures

Primary Outcomes (1)

  • Genetic polymorphism tests before azathioprine therapy may reduce toxicity

    current treatment to nausea/vomiting adverse effects induced by azathioprine combined with pre-therapeutic genetic screening, especially polymorphism ITPA C94A, may reduce the possibility for developing hematopoietic toxicity and/or hepatotoxicity.

    2008.1.1

Interventions

AzathioprineDRUG

azathioprine usual dosage 100mg per day

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese Han patients

You may qualify if:

  • Patients who have used or are using azathioprine in treating skin diseases will be asked about treatment effects and adverse events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Azathioprine

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Tsen-Fang Tsai, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 5, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

May 17, 2012

Record last verified: 2012-01

Locations

TW(1)