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CompletedNCT03665402Updated Feb 28, 2020

A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

An interventional study of Isoniazid in Tuberculosis, Drug-Induced Liver Injury and Adverse Drug Event, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Tuberculosis
  • Drug-Induced Liver Injury
  • Adverse Drug Event
03

In context

Tuberculosis

1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 16 is below the median of 150 across 963 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Rapid metabolizer (Standard treatment)

    Standard isoniazid dose regimen (300 mg qd)

    Drug: Isoniazid

  • Active comparator
    Slow metabolizer (Standard treatment)

    Standard isoniazid dose regimen (300 mg qd)

    Drug: Isoniazid

  • Experimental
    Slow metabolizer (PGx treatment)

    Decreased isoniazid dose regimen (200 mg qd)

    Drug: Isoniazid

Interventions

  • DrugIsoniazid

    One of the first line anti-tubercolosis drug

06

What researchers measure

Primary outcomes

  1. Liver toxicity

    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

    Time frame: up to 4 weeks

Secondary outcomes

  1. Drug exposure

    Plasma isoniazid concentration

    Time frame: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose

07

Study locations

1 site
  • Seoul National University Hospital Clinical Trials Center
    Seoul, 110-744, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Dec 2018, 7 months.

Of 191 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 7 months is below that.

Counting every sponsor, half of 193 studies reached it within 25 months; a quarter within 15 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2018
First posted
Sep 11, 2018
StartActual
May 13, 2018
Primary completionActual
Dec 31, 2018
CompletionActual
Mar 31, 2019
Last update
Feb 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03665402
Lead sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
Responsible party
Sponsor
First posted
Sep 11, 2018
Start date
May 13, 2018
Primary completion
Dec 31, 2018
Completion
Mar 31, 2019
Last update
Feb 28, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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