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

Osaka University

Status and phase: Completed; Phase 4

Conditions: Pulmonary Tuberculosis

Treatments: Drug: isoniazed; Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT00298870

PG-MRT-TB-01

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

PGx-treatment

Experimental group

Description:

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)

Treatment:

Drug: Isoniazid

STD-treatment

Active Comparator group

Description:

Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.)

Treatment:

Drug: isoniazed