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

This study is currently recruiting participants.

Verified by Osaka University, April 2005

Sponsored by:	Osaka University
Information provided by:	Osaka University
ClinicalTrials.gov Identifier:	NCT00298870

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	Phase IV

MedlinePlus related topics: Tuberculosis

Drug Information available for: Isoniazid Ftivazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Osaka University:

Study Start Date:

June 2005

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

Contacts

Contact: Masako Ohno, PhD

+81-6-6879-8163

ohno@phs.osaka-u.ac.jp

Locations

Japan, Osaka
National Hospital Organization Toneyama	Recruiting
Toyonaka, Osaka, Japan, 560-8552
National Hospital Organization Kinki-chuo Chest Medical Center	Not yet recruiting
Sakai, Osaka, Japan, 591-8555
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Recruiting
Habikino, Osaka, Japan, 583-8588
Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch	Not yet recruiting
Neyagawa, Osaka, Japan, 572-0801

Sponsors and Collaborators

Osaka University

Investigators

Study Chair:

Junichi Azuma, MD

Graduate School of Pharmaceutical Sciences, Osaka University

More Information

Study ID Numbers:	PG-MRT-TB-01
Study First Received:	March 2, 2006
Last Updated:	March 2, 2006
ClinicalTrials.gov Identifier:	NCT00298870
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

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Tuberculosis, pulmonary

Lung Diseases
Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis
Isoniazid

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Antitubercular Agents
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009