Reintroduction Regimens After Hepatitis During Anti-tuber... | NCT01395654

Studies
Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

NCT01395654

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 27, 2012Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Hepatitis
Tuberculosis, Pulmonary

Interventions

isoniazid, rifampin, pyrazinamide

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 5, 2011

First Submission Date that Met QC Criteria

Jul 14, 2011

First Posted Date

Jul 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2012

Last Update Posted Date

Dec 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard rechallenge, Slow rechallenge	Experimental		Drug: isoniazid, rifampin, pyrazinamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isoniazid, rifampin, pyrazinamide	Drug	rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis	Standard rechallenge, Slow rechallenge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The duration needed for successfully rechallenge anti-tuberculosis treatment		participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with recurrence of hepatitis		participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jann-Yuan Wang, MD	Contact	886-2-3123456		jywang@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Jann-Yuan Wang	National Taiwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chest Hospital	Recruiting	Tainan			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006505	Hepatitis
D014397	Tuberculosis, Pulmonary

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D014376	Tuberculosis
D009164	Mycobacterium Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007538	Isoniazid
D012293	Rifampin
D011718	Pyrazinamide

Ancestor Terms

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic

Browse Leaves

Not provided

Browse Branches

Not provided