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Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

NCT ID: NCT01395654

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Hepatitis Tuberculosis, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard rechallenge, Slow rechallenge

Group Type EXPERIMENTAL

isoniazid, rifampin, pyrazinamide

Intervention Type DRUG

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

Interventions

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isoniazid, rifampin, pyrazinamide

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

Intervention Type DRUG

Other Intervention Names

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INH RIF PZA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jann-Yuan Wang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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Chest Hospital

Tainan City, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jann-Yuan Wang, MD

Role: CONTACT

Phone: 886-2-3123456

Email: [email protected]

Facility Contacts

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Jung-Yien Chien

Role: primary

Jann-Yuan Wang

Role: primary

Other Identifiers

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201010025M

Identifier Type: -

Identifier Source: org_study_id