Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01395654
• Other study ID #: 201010025M
• Status: Recruiting
• Phase: Phase 4
• First received: July 5, 2011
• Last updated: December 26, 2012
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: Jann-Yuan Wang, MD
• Phone: 886-2-3123456
• Email: jywang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• isoniazid, rifampin, pyrazinamide
rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis

Locations

Country	Name	City	State
Taiwan	Chest Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of participants with recurrence of hepatitis		participants will be followed for the duration of hospital stay, an expected average of 5 weeks	Yes