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

Not Applicable

• Conditions: Hepatotoxicity
• Interventions: Drug: isoniazid

• Registration Number: NCT02076685
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2014-02-26
• Status Verified: 2014-03
• Study First Posted: 2014-03-03
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-17
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
isoniazid rechalleng	isoniazid	When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly.

Primary Outcome Measures

Name	Time	Method
successful re-use of isoniazid for TB treatment	6 months	In 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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan