NCT00728546

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 27, 2012

Status Verified

November 1, 2012

Enrollment Period

7.4 years

First QC Date

August 1, 2008

Last Update Submit

December 26, 2012

Conditions

TuberculosisHepatotoxicity

Keywords

tuberculosisisoniazidArylamine N-acetyl transferasegenotypinghepatotoxicitypharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • Decrease the events of hepatotoxicity when patients are re-challenged with INH

    6-12 months

Secondary Outcomes (1)

  • economics evaluation of performing pharmacogenetics screening in practice

    6-12 months

Study Arms (1)

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

Isoniazid (Rifinah)DRUG

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

Also known as: Isoniazid, Rifinah
INA dose adjustment, NAT2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years-old
  • Taken INH for more than 1 week
  • Abnormal liver function

You may not qualify if:

  • Rule out the INH induced liver abnormality
  • Existing reasons to cause liver abnormality other than TB-medication
  • Taking drugs which interact with INH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Li-Jiuan Shen, Ph.D.

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Jiuan Shen, Ph.D.

CONTACT

33933670ljshen@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 27, 2012

Record last verified: 2012-11

Locations

TW(1)