Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Descriptive Information
Brief Title ^†	Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Official Title ^†	Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment
Brief Summary	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.
Detailed 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.
Study Phase	Phase 4
Study Type ^†	Interventional
Study Design ^†	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure ^†	The duration needed for successfully rechallenge anti-tuberculosis treatment
Secondary Outcome Measure ^†	Number of participants with recurrence of hepatitis
Condition ^†	Hepatitis Tuberculosis, Pulmonary
Intervention ^†	Drugisoniazid, rifampin, pyrazinamide
Study Arms / Comparison Groups	Standard rechallenge, Slow rechallenge
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	100
Start Date ^†	July 2011
Completion Date	December 2015
Primary Completion Date	December 2013
Eligibility Criteria ^†	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
Gender	Both
Ages	18 Years - N/A
Accepts Healthy Volunteers	No
Contacts ^††	Jann-Yuan Wang, MD, 886-2-3123456, jywang@ntu.edu.tw , ,
Location Countries ^†	Taiwan,
Administrative Information
NCT ID ^†	NCT01395654
Organization ID	201010025M
Secondary IDs ^††
Responsible Party	,
Study Sponsor ^†	National Taiwan University Hospital
Collaborators ^††
Investigators ^†	Principal Investigator: Jann-Yuan Wang, National Taiwan University
Information Provided By	National Taiwan University Hospital
Verification Date	November 2012
First Received Date ^†	July 5, 2011
Last Updated Date	December 26, 2012

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.