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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

Page last updated: August 23, 2015

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