NAT2 in Re-challenge of INH in Patients With Hepatitis
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis; Hepatotoxicity
Intervention: Isoniazid (Rifinah) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s): Li-Jiuan Shen, Ph.D., Principal Investigator, Affiliation: National Taiwan University
Overall contact: Li-Jiuan Shen, Ph.D., Phone: 33933670, Email: ljshen@ntu.edu.tw
Summary
Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in
patients with anti-TB medication induced hepatitis.
Clinical Details
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
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Decrease the events of hepatotoxicity when patients are re-challenged with INH
Secondary outcome: economics evaluation of performing pharmacogenetics screening in practice
Detailed description:
adjusting INH dose according to NAT2 genotyping and serum concentration of INH.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Li-Jiuan Shen, Ph.D., Phone: 33933670, Email: ljshen@ntu.edu.tw
National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting Li-Jiuan Shen, Ph.D., Phone: 886-2-2312-3456, Ext: 8411, Email: ljshen@ntu.edu.tw Li-Jiuan Shen, Ph.D., Principal Investigator
Additional Information
Starting date: June 2008
Last updated: December 26, 2012
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