NAT2 in Re-challenge of INH in Patients With Hepatitis

NCT ID: NCT00728546

Last Updated: 2012-12-27

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-11-30

Brief Summary

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Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Detailed Description

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adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Conditions

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Tuberculosis Hepatotoxicity

Keywords

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tuberculosis isoniazid Arylamine N-acetyl transferase genotyping hepatotoxicity pharmacogenetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INA dose adjustment, NAT2

The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Group Type EXPERIMENTAL

Isoniazid (Rifinah)

Intervention Type DRUG

The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Interventions

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Isoniazid (Rifinah)

The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.

Intervention Type DRUG

Other Intervention Names

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Isoniazid Rifinah

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Jiuan Shen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

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

Phone: 33933670

Email: [email protected]

Facility Contacts

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Li-Jiuan Shen, Ph.D.

Role: primary

Other Identifiers

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20080515M

Identifier Type: -

Identifier Source: org_study_id