NCT02076685

Brief Summary

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.7 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

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

8 years

First QC Date

November 16, 2012

Last Update Submit

March 13, 2014

Conditions

Hepatotoxicity

Keywords

pharmacogeneticsanti-tuberculosis druggenetic polymorphismisoniazid

Outcome Measures

Primary Outcomes (1)

  • successful re-use of isoniazid for TB treatment

    In this study, we would like to test the hypothesis of NAT2 genotyping helping in isoniazid rechallenge after patients experienced adverse effects of anti-TB treatment. Therefore, to observe the patients can re-use isoniazid successfully is an important outcome measure in this study.

    6 months

Study Arms (1)

isoniazid rechalleng

EXPERIMENTAL

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

Drug: isoniazid

Interventions

isoniazidDRUG

dose adjustment according to the pharmacogenomic results

Also known as: Duracin, Rifina
isoniazid rechalleng

Eligibility Criteria

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

You may qualify if:

  • \>= 18 years.
  • Take INH for at least a week.
  • 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

You may not qualify if:

  • Taking INH before liver function abnormalities. 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Isoniazid

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Shen Li Jiuan, Ph.D

    Nationa Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Jiuan Shen, Ph.D.

CONTACT

ljshen@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

March 3, 2014

Study Start

November 1, 2007

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

TW(1)