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A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

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ClinicalTrials.gov Identifier: NCT03665402
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects

Condition or disease Intervention/treatment Phase
Tuberculosis Drug-Induced Liver Injury Adverse Drug Event Drug: Isoniazid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
Actual Study Start Date : May 13, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Isoniazid

Arm Intervention/treatment
Active Comparator: Rapid metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug

Active Comparator: Slow metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug

Experimental: Slow metabolizer (PGx treatment)
Decreased isoniazid dose regimen (200 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug




Primary Outcome Measures :
  1. Liver toxicity [ Time Frame: up to 4 weeks ]

    Number of participants with drug-induced liver injury as assessed by below criteria.

    • AST or ALT > 5 ULN
    • AST or ALT > 3 ULN and total bilirubin > 2 ULN (Hy's law case)
    • ALT ratio/ALP ratio > 5


Secondary Outcome Measures :
  1. Drug exposure [ Time Frame: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose ]
    Plasma isoniazid concentration



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agreement with written informed consent
  • Adult healthy male or female subject age 20 to 45

Exclusion Criteria:

  • Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
  • Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days
  • Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
  • Subject with known for hypersensitivity reactions to isoniazid
  • Subject who can not perform contraception during study periods
  • Female woman who are pregnant or are breast feeding
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Information from the National Library of Medicine

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): NCT03665402


Locations
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Korea, Republic of
Seoul National University Hospital Clinical Trials Center Recruiting
Seoul, Korea, Republic of, 110-744
Contact: In-Jin Jang, MD    +82-2-2072-1930    ijjang@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03665402     History of Changes
Other Study ID Numbers: INH NAT2
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tuberculosis
Chemical and Drug Induced Liver Injury
Drug-Related Side Effects and Adverse Reactions
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chemically-Induced Disorders
Liver Diseases
Digestive System Diseases
Poisoning
Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents