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

NCT ID: NCT02076685

Last Updated: 2014-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Hepatotoxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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isoniazid rechalleng

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

Group Type EXPERIMENTAL

isoniazid

Intervention Type DRUG

dose adjustment according to the pharmacogenomic results

Interventions

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isoniazid

dose adjustment according to the pharmacogenomic results

Intervention Type DRUG

Other Intervention Names

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Duracin, Rifina

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shen Li Jiuan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nationa Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Jiuan Shen, Ph.D.

Role: CONTACT

Facility Contacts

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Li-Jiuan Shen, Ph.D.

Role: primary

Other Identifiers

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200805015M

Identifier Type: -

Identifier Source: org_study_id

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