Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis Tuberculosis, Pulmonary |
Drug: isoniazid, rifampin, pyrazinamide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Standard rechallenge, Slow rechallenge |
Drug: isoniazid, rifampin, pyrazinamide
rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01395654 History of Changes |
| Other Study ID Numbers: | 201010025M |
| Study First Received: | July 5, 2011 |
| Last Updated: | December 26, 2012 |
| Health Authority: | Taiwan: Department of Health |
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 Pyrazinamide Rifampin Isoniazid Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers |
ClinicalTrials.gov processed this record on September 27, 2016