Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Primary Purpose
Hepatitis, Tuberculosis, Pulmonary
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
isoniazid, rifampin, pyrazinamide
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis
Eligibility 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
Sites / Locations
- Chest HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard rechallenge, Slow rechallenge
Arm Description
Outcomes
Primary Outcome Measures
The duration needed for successfully rechallenge anti-tuberculosis treatment
Secondary Outcome Measures
Number of participants with recurrence of hepatitis
Full Information
NCT ID
NCT01395654
First Posted
July 5, 2011
Last Updated
December 26, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01395654
Brief Title
Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
Official Title
Different Reintroduction Regimens of Antituberculosis Drugs After Development of Hepatitis During Anti-tuberculosis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Tuberculosis, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard rechallenge, Slow rechallenge
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
isoniazid, rifampin, pyrazinamide
Other Intervention Name(s)
INH, RIF, PZA
Intervention Description
rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jann-Yuan Wang, MD
Phone
886-2-3123456
Email
jywang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jann-Yuan Wang
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chest Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Yien Chien
Phone
886-6-2705911
Ext
3206
Email
jychien@ntu.edu.tw
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jann-Yuan Wang
Phone
23123456
Email
jywang@ntu.edu.tw
12. IPD Sharing Statement
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Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment
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