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Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment

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.

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.

Phase 4
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The duration needed for successfully rechallenge anti-tuberculosis treatment
Number of participants with recurrence of hepatitis
  • Hepatitis
  • Tuberculosis, Pulmonary
Drugisoniazid, rifampin, pyrazinamide
  • Standard rechallenge, Slow rechallenge

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Drug
100
July 2011
December 2015
December 2013

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

Both
18 Years - N/A
No
  • Jann-Yuan Wang, MD, 886-2-3123456, jywang@ntu.edu.tw
  • , ,
Taiwan,
NCT01395654
201010025M
,
National Taiwan University Hospital
    Principal Investigator: Jann-Yuan Wang, National Taiwan University
    National Taiwan University Hospital
    November 2012
    July 5, 2011
    December 26, 2012
    Required WHO trial registration data element.
    †† WHO trial registration data element that is required only if it exists.