Hepatotoxicity, Tuberculosis
Conditions
Keywords
tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
Brief summary
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.
Interventions
DRUGIsoniazid (Rifinah)
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
Sponsors
Department of Health, Executive Yuan, R.O.C. (Taiwan)
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years-old * Taken INH for more than 1 week * Abnormal liver function
Exclusion criteria
* Rule out the INH induced liver abnormality * Existing reasons to cause liver abnormality other than TB-medication * Taking drugs which interact with INH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease the events of hepatotoxicity when patients are re-challenged with INH | 6-12 months |
Secondary
| Measure | Time frame |
|---|---|
| economics evaluation of performing pharmacogenetics screening in practice | 6-12 months |
Countries
Taiwan
Contacts
Primary ContactLi-Jiuan Shen, Ph.D.
Outcome results
None listed