Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

National Taiwan University logo

National Taiwan University

Status and phase

Unknown
Phase 4

Conditions

Hepatitis
Tuberculosis, Pulmonary

Treatments

Drug: isoniazid, rifampin, pyrazinamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01395654
201010025M

Details and patient eligibility

About

Despite the availability of effective anti-tuberculosis agents that exist to treat this illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use. There is no consensus on method of the reintroduction of anti-TB medications. The risk of reintroducing of a anti-TB medications could be hazardous. There are several differences between the guidelines from the ATS, BTS and the Task Force of the European Respiratory Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the methods of reintroducing of anti-TB medications. The investigators plan to do a prospective study to evaluate the outcome and safety of reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment among TB patients in the investigators hospital.

Full description

Tuberculosis (TB) remains a leading health problem in both developing and developed countries. Despite the availability of effective chemotherapeutic agents that exist to treat this illness, hepatotoxicity during first-line drugs anti-tuberculosis medications (ATT) such as isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) is not uncommon and limit their use. In the case of confirmed moderate or severe drug-induced hepatotoxicity, treatment should be interrupted and reintroduced after the hepatotoxicity has resolved. There is no consensus on method of the reintroduction of anti-TB medications. The risk of reintroducing of a anti-TB medications could be hazardous. There are several differences between the guidelines from the ATS, BTS and the Task Force of the European Respiratory Society, the WHO and the International Union Against Tuberculosis and Lung Disease about the methods of reintroducing of anti-TB medications. We plan to do a prospective study to evaluate the outcome and safety of reintroduction of anti-TB medications after resolution of hepatitis during anti-TB treatment among TB patients in our hospital.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hepatitis during anti-tuberculosis treatment
  • Hold RMP, INH and PZA after hepatitis
  • Age >= 18 years old
  • HIV(-)
  • T-bilirubin < 2.5 mg/dL
  • No allergy to RMP, INH and PZA

Exclusion criteria

  • Liver cirrhosis, child B or C
  • Pregnancy and breast feeding
  • Life expectation < 1 year

Trial design

100 participants in 1 patient group

Standard rechallenge, Slow rechallenge
Experimental group
Treatment:
Drug: isoniazid, rifampin, pyrazinamide

Trial contacts and locations

0

Loading...

Central trial contact

Jann-Yuan Wang, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems