Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
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ClinicalTrials.gov Identifier: NCT00298870 |
Recruitment Status :
Completed
First Posted : March 3, 2006
Last Update Posted : October 18, 2012
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Tuberculosis | Drug: Isoniazid Drug: isoniazed | Phase 4 |
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 |

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)
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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.)
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Drug: isoniazed
Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all |
- The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism1) 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
- Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy

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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

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
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 |
Study Chair: | Junichi Azuma, MD | Graduate School of Pharmaceutical Sciences, Osaka University |
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 Posted: | March 3, 2006 Key Record Dates |
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 |