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

NCT ID: NCT00298870

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Tuberculosis

Keywords

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pulmonary tuberculosis isoniazid arylamine N-acetyltransferase 2 pharmacogenomics genetic polymorphisms individualized medicine drug-induced hepatotoxity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Isoniazid

Intervention Type DRUG

Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively

STD-treatment

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

Group Type ACTIVE_COMPARATOR

isoniazed

Intervention Type DRUG

Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

Interventions

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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

Intervention Type DRUG

isoniazed

Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osaka University

OTHER

Sponsor Role lead

Principal Investigators

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Junichi Azuma, MD

Role: STUDY_CHAIR

Graduate School of Pharmaceutical Sciences, Osaka University

Locations

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Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Habikino, Osaka, Japan

Site Status

Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch

Neyagawa, Osaka, Japan

Site Status

National Hospital Organization Kinki-chuo Chest Medical Center

Sakai, Osaka, Japan

Site Status

National Hospital Organization Toneyama

Toyonaka, Osaka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 23150149 (View on PubMed)

Other Identifiers

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PG-MRT-TB-01

Identifier Type: -

Identifier Source: org_study_id