Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
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ClinicalTrials.gov Identifier: NCT01395654 |
Recruitment Status
: Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted
: July 15, 2011
Last Update Posted
: December 27, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis Tuberculosis, Pulmonary | Drug: isoniazid, rifampin, pyrazinamide | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated 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 : | July 2011 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2015 |
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:
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- The duration needed for successfully rechallenge anti-tuberculosis treatment [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]
- Number of participants with recurrence of hepatitis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395654
Contact: Jann-Yuan Wang, MD | 886-2-3123456 | jywang@ntu.edu.tw |
Taiwan | |
Chest Hospital | Recruiting |
Tainan, Taiwan | |
Contact: Jung-Yien Chien 886-6-2705911 ext 3206 jychien@ntu.edu.tw | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Jann-Yuan Wang 23123456 jywang@ntu.edu.tw |
Principal Investigator: | Jann-Yuan Wang | National Taiwan University |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT01395654 History of Changes |
Other Study ID Numbers: |
201010025M |
First Posted: | July 15, 2011 Key Record Dates |
Last Update Posted: | December 27, 2012 |
Last Verified: | November 2012 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Tuberculosis Tuberculosis, Pulmonary Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Rifampin Isoniazid Pyrazinamide Antitubercular Agents Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers |