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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02076685
Enrollment
60
Registered
2014-03-03
Start date
2007-11-30
Completion date
2015-11-30
Last updated
2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatotoxicity

Keywords

pharmacogenetics, anti-tuberculosis drug, genetic polymorphism, isoniazid

Brief 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.

Interventions

DRUGisoniazid

dose adjustment according to the pharmacogenomic results

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

1.Taking INH before liver function abnormalities. 2.

Design outcomes

Primary

MeasureTime frameDescription
successful re-use of isoniazid for TB treatment6 monthsIn 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.

Countries

Taiwan

Contacts

Primary ContactLi-Jiuan Shen, Ph.D.
ljshen@ntu.edu.tw

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026