TuberculosisPhase 4NCT00728546
NAT2 in Re-challenge of INH in Patients With Hepatitis
A Phase 4 study testing Isoniazid (Rifinah) in people with Tuberculosis and Hepatotoxicity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Hepatotoxicity
- What is being tested?
- Isoniazid (Rifinah)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to Nov 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years-old
- Taken INH for more than 1 week
- Abnormal liver function
Who cannot join
- Rule out the INH induced liver abnormality
- Existing reasons to cause liver abnormality other than TB-medication
- Taking drugs which interact with INH
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Li-Jiuan Shen, Ph.D., 886-2-2312-3456 ext. 8411, ljshen@ntu.edu.tw
Li-Jiuan Shen, Ph.D.
About this study
Official title: The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.
Read the detailed description
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.
- Conditions
- Tuberculosis, Hepatotoxicity
- Being tested
- Isoniazid (Rifinah)
- Keywords
- tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid (Rifinah)Drug
Also called Isoniazid, Rifinah
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
| Study group | Role | What they receive |
|---|---|---|
| INA dose adjustment, NAT2 | Experimental | The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient. Receives: Drug: Isoniazid (Rifinah) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease the events of hepatotoxicity when patients are re-challenged with INH
Measured: 6-12 months
Secondary outcomes (1)
economics evaluation of performing pharmacogenetics screening in practice
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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 National Taiwan 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Responsible party
- Sponsor
- Investigators
- Li-Jiuan Shen, Ph.D., Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728546
- Sponsor's protocol ID
- 20080515M
- Status last verified
- Nov 2012
- First submitted
- 1 Aug 2008
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
- ClinicalTrials.gov ID
- NCT00728546
- Acronym / sponsor ID
- 20080515M
- Conditions
- Tuberculosis, Hepatotoxicity
- Keywords
- tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Jun 2008
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 6 Aug 2008 (estimated)
- 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.
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.
Detailed description
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INA dose adjustment, NAT2 | Experimental | Drug: Isoniazid (Rifinah)The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years-old
- Taken INH for more than 1 week
- Abnormal liver function
Key exclusion criteria (3 listed)
- Rule out the INH induced liver abnormality
- Existing reasons to cause liver abnormality other than TB-medication
- Taking drugs which interact with INH
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 |
|---|---|---|
| Isoniazid (Rifinah)Also: Isoniazid, RifinahThe dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient. | Drug | INA dose adjustment, NAT2 |
Primary outcome
Decrease the events of hepatotoxicity when patients are re-challenged with INH
Time frame: 6-12 months
1 secondary outcome
economics evaluation of performing pharmacogenetics screening in practice
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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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.
Li-Jiuan Shen, Ph.D. principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoniazid (Rifinah) in people with Tuberculosis and Hepatotoxicity, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Dec 2012. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Jiuan Shen, Ph.D. (33933670, ljshen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the events of hepatotoxicity when patients are re-challenged with INH (time frame: 6-12 months). 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 27 Dec 2012.