Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01395654
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Duration (Months): 53
• Patients Per Site: 50
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis; Tuberculosis, Pulmonary	Drug: isoniazid, rifampin, pyrazinamide	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard rechallenge, Slow rechallenge	Drug: isoniazid, rifampin, pyrazinamide; rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis; Other Names: INH RIF PZA

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of participants with recurrence of hepatitis [participants will be followed for the duration of hospital stay, an expected average of 5 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chest Hospital	Tainan		Taiwan
2	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Jann-Yuan Wang, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01395654
• Other Study ID Numbers: 201010025M
• First Posted: Jul 15, 2011
• Last Update Posted: Dec 27, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Hepatitis A; Tuberculosis; Tuberculosis, Pulmonary; Hepatitis; Rifampin; Isoniazid; Pyrazinamide

Study Results

No Results Posted as of Dec 27, 2012