Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Phase 4

• Conditions: Tuberculosis, Pulmonary; Hepatitis
• Interventions: Drug: isoniazid, rifampin, pyrazinamide

• Registration Number: NCT01395654
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Status Verified: 2012-11
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard rechallenge, Slow rechallenge	isoniazid, rifampin, pyrazinamide	-

Primary Outcome Measures

Name	Time	Method
The duration needed for successfully rechallenge anti-tuberculosis treatment	participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with recurrence of hepatitis	participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Trial Locations

Locations (2)

Chest Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan