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

This study has been completed.
Sponsor:
Information provided by:
Osaka University
ClinicalTrials.gov Identifier:
NCT00298870
First received: March 2, 2006
Last updated: October 17, 2012
Last verified: May 2011
  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
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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
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
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
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 22, 2014