NAT2 in Re-challenge of INH in Patients With Hepatitis

Phase 4

• Conditions: Tuberculosis; Hepatotoxicity
• Interventions: Drug: Isoniazid (Rifinah)

• Registration Number: NCT00728546
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INA dose adjustment, NAT2	Isoniazid (Rifinah)	The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Primary Outcome Measures

Name	Time	Method
Decrease the events of hepatotoxicity when patients are re-challenged with INH	6-12 months

Secondary Outcome Measures

Name	Time	Method
economics evaluation of performing pharmacogenetics screening in practice	6-12 months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan