Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01395654
First received: July 5, 2011
Last updated: December 26, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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:
  • INH
  • RIF
  • PZA

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
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Antitubercular Agents
Isoniazid
Pyrazinamide
Rifampin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014