Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Standard rechallenge, Slow rechallenge

Experimental group

Treatment:

Drug: isoniazid, rifampin, pyrazinamide