Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard dosing
a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight
No interventions assigned to this group
Genotype-guided dosing
INH dose determined based on developed model
genotype
Patients were randomly assigned to a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight) or model-based treatment group; INH dose determined based on developed model,
Interventions
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genotype
Patients were randomly assigned to a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight) or model-based treatment group; INH dose determined based on developed model,
Eligibility Criteria
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Inclusion Criteria
* Given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months.
* Those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-TB treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to INH at the start of treatment were excluded.
17 Years
80 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Soo-Youn Lee, MD
Role: PRINCIPAL_INVESTIGATOR
SMC
Locations
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Samsung Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Soo-Youn Lee
Role: primary
Other Identifiers
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SMC-2013-07-155-002
Identifier Type: -
Identifier Source: org_study_id
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