drugset / Trial / NCT00571753

Isoniazid Dose Adjustment According to NAT2 Genotype (IDANAT2)

NCT00571753 ↗

Phase 3 Terminated 900 enrolled University of Cologne
RandomizedParallel-groupTriple-blindTreatment

Summary

The study is conducted to compare safety and efficacy of isoniazid administered as an adjusted dose based on NAT2 (arylamine N-acetyltransferase type 2)genotype and as a standard dose. The hypothesis is that the genotype-adjusted dose is superior to the standard dose with regard to hepatotoxicity and early treatment failure, respectively, in the group of slow and rapid acetylators of NAT2.

Timeline

Start
2008-06
Primary completion
2011-12
Completion
2012-02

Outcome

Outcome not reported

Stopped (Enrollment): “Enrolling participants has halted prematurely due to a low recruitment rate.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isoniazid Small molecule 2.5 mg/kg —
Comparator Isoniazid Small molecule 5 mg/kg —
Comparator Isoniazid Small molecule 7.5 mg/kg —