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

This study has been completed.
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
First received: March 2, 2006
Last updated: October 17, 2012
Last verified: May 2011

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.

Condition Intervention Phase
Pulmonary Tuberculosis
Drug: Isoniazid
Drug: isoniazed
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Osaka University:

Primary Outcome Measures:
  • 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:
  • Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

Enrollment: 172
Study Start Date: June 2005
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298870

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, Japan, 583-8588
Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch
Neyagawa, Osaka, Japan, 572-0801
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai, Osaka, Japan, 591-8555
National Hospital Organization Toneyama
Toyonaka, Osaka, Japan, 560-8552
Sponsors and Collaborators
Osaka University
Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
  More Information

No publications provided by Osaka University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00298870     History of Changes
Other Study ID Numbers: PG-MRT-TB-01
Study First Received: March 2, 2006
Last Updated: October 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:
pulmonary tuberculosis
arylamine N-acetyltransferase 2
genetic polymorphisms
individualized medicine
drug-induced hepatotoxity

Additional relevant MeSH terms:
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 23, 2014