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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298870
First Posted: March 3, 2006
Last Update Posted: October 18, 2012
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.
Information provided by:
Osaka University
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00298870


Locations
Japan
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
Investigators
Study Chair: Junichi Azuma, MD Graduate School of Pharmaceutical Sciences, Osaka University
  More Information

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
First Submitted: March 2, 2006
First Posted: March 3, 2006
Last Update Posted: October 18, 2012
Last Verified: May 2011

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

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