NAT2 in Re-challenge of INH in Patients With Hepatitis | NCT00728546

Studies
NAT2 in Re-challenge of INH in Patients With Hepatitis

NCT00728546

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 27, 2012Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Tuberculosis
Hepatotoxicity

Interventions

Isoniazid (Rifinah)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Aug 1, 2008

First Submission Date that Met QC Criteria

Aug 5, 2008

First Posted Date

Aug 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2012

Last Update Posted Date

Dec 27, 2012Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INA dose adjustment, NAT2	Experimental	The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.	Drug: Isoniazid (Rifinah)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isoniazid (Rifinah)	Drug	The dose of the re-challenged INH is followed by the results of the genotyping of NAT2 in each patient.	INA dose adjustment, NAT2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease the events of hepatotoxicity when patients are re-challenged with INH		6-12 months

Secondary Outcomes

Measure	Description	Time Frame
economics evaluation of performing pharmacogenetics screening in practice		6-12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li-Jiuan Shen, Ph.D.	Contact	33933670		ljshen@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Li-Jiuan Shen, Ph.D.	National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007538	Isoniazid

Ancestor Terms

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic

Browse Leaves

Not provided

Browse Branches

Not provided