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

Pulmonary Tuberculosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298870
• Other study ID #: PG-MRT-TB-01
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2006
• Last updated: October 17, 2012
• Start date: June 2005

Study information

• Verified date: May 2011
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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
• isoniazed
Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all

Locations

Country	Name	City	State
Japan	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Habikino	Osaka
Japan	Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch	Neyagawa	Osaka
Japan	National Hospital Organization Kinki-chuo Chest Medical Center	Sakai	Osaka
Japan	National Hospital Organization Toneyama	Toyonaka	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy