Back to resultsNAT2 in Re-challenge of INH in Patients With Hepatitis
Primary Purpose
Tuberculosis, Hepatotoxicity
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Isoniazid (Rifinah)
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INA dose adjustment, NAT2
Arm Description
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
Outcomes
Primary Outcome Measures
Decrease the events of hepatotoxicity when patients are re-challenged with INH
Secondary Outcome Measures
economics evaluation of performing pharmacogenetics screening in practice
Full Information
NCT ID
NCT00728546
First Posted
August 1, 2008
Last Updated
December 26, 2012
Sponsor
National Taiwan University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
1. Study Identification
Unique Protocol Identification Number
NCT00728546
Brief Title
NAT2 in Re-challenge of INH in Patients With Hepatitis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Department of Health, Executive Yuan, R.O.C. (Taiwan)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Hepatotoxicity
Keywords
tuberculosis, isoniazid, Arylamine N-acetyl transferase, genotyping, hepatotoxicity, pharmacogenetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INA dose adjustment, NAT2
Arm Type
Experimental
Arm Description
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
Intervention Type
Drug
Intervention Name(s)
Isoniazid (Rifinah)
Other Intervention Name(s)
Isoniazid, Rifinah
Intervention Description
The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.
Primary Outcome Measure Information:
Title
Decrease the events of hepatotoxicity when patients are re-challenged with INH
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
economics evaluation of performing pharmacogenetics screening in practice
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Jiuan Shen, Ph.D.
Phone
33933670
Email
ljshen@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Jiuan Shen, Ph.D.
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Jiuan Shen, Ph.D.
Phone
886-2-2312-3456
Ext
8411
Email
ljshen@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Li-Jiuan Shen, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
NAT2 in Re-challenge of INH in Patients With Hepatitis
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