Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

This study has been completed.
Sponsor:
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT00298870
First received: March 2, 2006
Last updated: October 17, 2012
Last verified: May 2011

March 2, 2006
October 17, 2012
June 2005
Not Provided
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
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Complete list of historical versions of study NCT00298870 on ClinicalTrials.gov Archive Site
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy
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Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Tuberculosis
  • Drug: Isoniazid
    Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively
  • Drug: isoniazed
    Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all
  • Experimental: PGx-treatment
    NAT2 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)
    Intervention: Drug: Isoniazid
  • Active Comparator: STD-treatment
    Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.)
    Intervention: Drug: isoniazed
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
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Inclusion Criteria:

  • Newly diagnosed pulmonary tuberculosis patients
  • Informed consent including pharmacogenomic analysis

Exclusion Criteria:

  • Abnormal liver and kidney function test before treatment
  • Long-term use of steroids and/or immunodepressants
  • Inadequate clinical conditions
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00298870
PG-MRT-TB-01
Yes
Not Provided
Osaka University
Not Provided
Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
Osaka University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP