Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01395654
First received: July 5, 2011
Last updated: December 26, 2012
Last verified: November 2012

July 5, 2011
December 26, 2012
July 2011
December 2013   (final data collection date for primary outcome measure)
The duration needed for successfully rechallenge anti-tuberculosis treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01395654 on ClinicalTrials.gov Archive Site
Number of participants with recurrence of hepatitis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis
  • Tuberculosis, Pulmonary
Drug: isoniazid, rifampin, pyrazinamide
rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis
Other Names:
  • INH
  • RIF
  • PZA
Experimental: Standard rechallenge, Slow rechallenge
Intervention: Drug: isoniazid, rifampin, pyrazinamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2013   (final data collection date for primary outcome measure)

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 and older
No
Contact: Jann-Yuan Wang, MD 886-2-3123456 jywang@ntu.edu.tw
Taiwan
 
NCT01395654
201010025M
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jann-Yuan Wang National Taiwan University
National Taiwan University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP