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

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.

Timeline

Start

2005-06

Primary completion

—

Completion

—

Outcome

Met primary endpoint

paper INH-DILI occurred in 78 % of the slow acetylators in the STD-treatment, while none of the slow acetylators in the PGx-treatment PMID 23150149 ↗

paper early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment PMID 23150149 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isoniazid	Small molecule	2.5 mg/kg	—
Subject	Isoniazid	Small molecule	5 mg/kg	—
Subject	Isoniazid	Small molecule	7.5 mg/kg	—

Indications