TuberculosisNCT03665402
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
A study testing Isoniazid in people with Tuberculosis and Drug-Induced Liver Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
- What is being tested?
- Isoniazid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trials Center
Seoul, 110-744
About this study
Official title: Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
- Conditions
- Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
- Being tested
- Isoniazid
- Medical subject headings
- Tuberculosis, Chemical and Drug Induced Liver Injury, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
One of the first line anti-tubercolosis drug
| Study group | Role | What they receive |
|---|---|---|
| Rapid metabolizer (Standard treatment) | Active comparator | Standard isoniazid dose regimen (300 mg qd) Receives: Drug: Isoniazid |
| Slow metabolizer (Standard treatment) | Active comparator | Standard isoniazid dose regimen (300 mg qd) Receives: Drug: Isoniazid |
| Slow metabolizer (PGx treatment) | Experimental | Decreased isoniazid dose regimen (200 mg qd) Receives: Drug: Isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 weeks
Secondary outcomes (1)
Drug exposure
Plasma isoniazid concentration
Measured: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start13 May 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665402
- Sponsor's protocol ID
- INH NAT2
- Status last verified
- Dec 2018
- First submitted
- 21 Aug 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
- ClinicalTrials.gov ID
- NCT03665402
- Acronym / sponsor ID
- INH NAT2
- Conditions
- Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 13 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapid metabolizer (Standard treatment) | Active comparator | Drug: IsoniazidStandard isoniazid dose regimen (300 mg qd) |
| Slow metabolizer (Standard treatment) | Active comparator | Drug: IsoniazidStandard isoniazid dose regimen (300 mg qd) |
| Slow metabolizer (PGx treatment) | Experimental | Drug: IsoniazidDecreased isoniazid dose regimen (200 mg qd) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoniazidOne of the first line anti-tubercolosis drug | Drug | Rapid metabolizer (Standard treatment), Slow metabolizer (PGx treatment), Slow metabolizer (Standard treatment) |
Primary outcome
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
1 secondary outcome
Drug exposure
Time frame: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid in people with Tuberculosis and Drug-Induced Liver Injury, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver toxicity (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.