ClinicalTrials.gov
ClinicalTrials.gov Menu

Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Jann-Yuan Wang, MD 886-2-3123456 jywang@ntu.edu.tw

Locations
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   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jann-Yuan Wang National Taiwan University
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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