Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
1 other identifier
interventional
172
1 country
4
Brief Summary
The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
4 active sites
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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 2, 2006
CompletedFirst Posted
Study publicly available on registry
March 3, 2006
CompletedOctober 18, 2012
May 1, 2011
March 2, 2006
October 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
1\) the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week
Secondary Outcomes (1)
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy
Study Arms (2)
PGx-treatment
EXPERIMENTALNAT2 genotype-guided treatment with stratified isoniazid dose (approx. 7.5 mg/kg b.w., patients homozygous for NAT2\*4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2\*4: intermediate acetylators; 2.5 mg/kg, patientes without NAT2\*4: slow acetylators)
STD-treatment
ACTIVE COMPARATORTreatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.)
Interventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed pulmonary tuberculosis patients
- Informed consent including pharmacogenomic analysis
You may not qualify if:
- Abnormal liver and kidney function test before treatment
- Long-term use of steroids and/or immunodepressants
- Inadequate clinical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osaka Universitylead
Study Sites (4)
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, 583-8588, Japan
Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch
Neyagawa, Osaka, 572-0801, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
National Hospital Organization Toneyama
Toyonaka, Osaka, 560-8552, Japan
Related Publications (1)
Azuma J, Ohno M, Kubota R, Yokota S, Nagai T, Tsuyuguchi K, Okuda Y, Takashima T, Kamimura S, Fujio Y, Kawase I; Pharmacogenetics-based tuberculosis therapy research group. NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy. Eur J Clin Pharmacol. 2013 May;69(5):1091-101. doi: 10.1007/s00228-012-1429-9. Epub 2012 Nov 14.
PMID: 23150149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junichi Azuma, MD
Graduate School of Pharmaceutical Sciences, Osaka University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2006
First Posted
March 3, 2006
Study Start
June 1, 2005
Last Updated
October 18, 2012
Record last verified: 2011-05