Pulmonary Tuberculosis Clinical Trial
Official title:
A Double-blind, Multicentre, Parallel Group, Randomised, Controlled Trial to Evaluate the Possible Benefit of Isoniazid Dose Adjustment According to the Genotype for NAT2 (Arylamine N-acetyltransferase Type 2) in Patients With Pulmonary Tuberculosis
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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