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Status unknownNCT02076685Updated Mar 17, 2014

NAT2 Genotyping in Re-challenge Protocol of INH Titration in Patients With Anti-TB Medications-induced Hepatitis

An interventional study of isoniazid in Hepatotoxicity, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-17.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To improve the treatment outcome in patients with tuberculosis and integrate the pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis medication-induced hepatitis.

02

Conditions studied

  • Hepatotoxicity

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Keywords

  • pharmacogenetics
  • anti-tuberculosis drug
  • genetic polymorphism
  • isoniazid
03

In context

Hepatitis

3,380 studies on the registry are indexed under Hepatitis; 202 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 2,388 interventional studies indexed under Hepatitis.

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Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 568 are open to participants now.

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

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. >= 18 years.
  2. Take INH for at least a week.
  3. abnormal liver function (ALT (alanine, transaminase) increased by more than three times the upper limit of normal, or ALT higher than twice the upper limit of normal and total bilirubin higher than 2.0 mg / dL

Exclusion criteria

Exclusion Criteria:

1.Taking INH before liver function abnormalities. 2.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    isoniazid rechalleng

    When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly.

    Drug: isoniazid

Interventions

  • Drugisoniazid

    dose adjustment according to the pharmacogenomic results

    Also known as: Duracin, Rifina

06

What researchers measure

Primary outcomes

  1. successful re-use of isoniazid for TB treatment

    In this study, we would like to test the hypothesis of NAT2 genotyping helping in isoniazid rechallenge after patients experienced adverse effects of anti-TB treatment. Therefore, to observe the patients can re-use isoniazid successfully is an important outcome measure in this study.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • Li-Jiuan Shen, Ph.D. · Contact · ljshen@ntu.edu.tw
    • Li-Jiuan Shen, Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02076685
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Mar 3, 2014
Start date
Nov 2007
Primary completion
Nov 2015 (estimated)
Completion
Nov 2015 (estimated)
Last update
Mar 17, 2014

Study contacts

Li-Jiuan Shen, Ph.D.
Contact
ljshen@ntu.edu.tw
Shen Li Jiuan, Ph.D
principal investigator · Nationa Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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