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

Phase 4

Completed

• Conditions: Pulmonary Tuberculosis
• Interventions: Drug: isoniazed; Drug: Isoniazid

• Registration Number: NCT00298870
• Lead Sponsor: Osaka University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-03
• Status Verified: 2011-05
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STD-treatment	isoniazed	Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.)
PGx-treatment	Isoniazid	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

Trial Locations

Locations (4)

National Hospital Organization Kinki-chuo Chest Medical Center; 🇯🇵 Sakai, Osaka, Japan

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases; 🇯🇵 Habikino, Osaka, Japan

Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch; 🇯🇵 Neyagawa, Osaka, Japan

National Hospital Organization Toneyama; 🇯🇵 Toyonaka, Osaka, Japan