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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298870
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : October 18, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Drug: Isoniazid Drug: isoniazed Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Isoniazid

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

Primary Outcome Measures :
  1. 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 :
  1. Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298870

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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
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Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00298870    
Other Study ID Numbers: PG-MRT-TB-01
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: May 2011
Keywords provided by Osaka University:
pulmonary tuberculosis
arylamine N-acetyltransferase 2
genetic polymorphisms
individualized medicine
drug-induced hepatotoxity
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents