Reintroduction Regimens After Hepatitis During Anti-tuberculosis Treatment

NCT01395654 | Unknown Phase 4

• 1 other identifier: 201010025M
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis; Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Number of participants with recurrence of hepatitis

  participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Study Arms (1)

Standard rechallenge, Slow rechallenge

EXPERIMENTAL

Drug: isoniazid, rifampin, pyrazinamide

Interventions

isoniazid, rifampin, pyrazinamide DRUG

rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis

Also known as: INH, RIF, PZA

Standard rechallenge, Slow rechallenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Liver cirrhosis, child B or C
• Pregnancy and breast feeding
• Life expectation \< 1 year

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

Chest Hospital

Tainan, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis; Tuberculosis, Pulmonary

Interventions

Isoniazid; Rifampin; Pyrazinamide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Pyrazines

Study Officials

• Jann-Yuan Wang

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jann-Yuan Wang, MD

CONTACT

886-2-3123456; jywang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 15, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: December 27, 2012

Record last verified: 2012-11

Locations

TW (2)