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

October 17, 2012 updated by: Osaka University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Habikino, Osaka, Japan, 583-8588
        • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
      • Neyagawa, Osaka, Japan, 572-0801
        • Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center
      • Toyonaka, Osaka, Japan, 560-8552
        • National Hospital Organization Toneyama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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
Active Comparator: STD-treatment
Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.)
Drug: isoniazed
Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Investigators

  • Study Chair: Junichi Azuma, MD, Graduate School of Pharmaceutical Sciences, Osaka University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (Estimate)

March 3, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG-MRT-TB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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