Status:
COMPLETED
Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Anti-TB Drugs Induced Liver Damage
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Drug Induced Hepatotoxicity
Tuberculosis
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
Purpose of the study is to evaluate the safety and efficacy of different re-introduction regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such patients who develo...
Detailed Description
Tuberculosis continues to be a major health problem in both the developing and developed countries because of its resurgence in the immunosuppressed patients. Short course chemotherapy containing ison...
Eligibility Criteria
Inclusion
- A rise of five times the upper limit of the normal levels (50 IU/L) of serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)
- A rise in the level of serum total bilirubin level \> 1.5mg/dl
- Any increase in serum AST and or ALT above pretreatment values together with anorexia, nausea, vomiting and jaundice
- Absence of serological evidence of infection with hepatitis viruses A,B,C,or E
- Normalization of liver function tests after withdrawal of antituberculosis drugs For diagnosis of anti-TB drugs induced hepatitis, criteria 1 or 2 or 3 should be present along with criteria 4 and 5.
Exclusion
- Patients with serological evidence of acute viral hepatitis A,B,C,or E and carriers for HBV \& HCV
- Age \< 15 year and age \> 65 years
- HIV positive patients
- Presence of chronic liver disease or cirrhosis
- Co-administration of other potential hepatotoxic drugs (methotrexate, phenytoin, valproate)
- Chronic alcoholics who consume \> 48 g of alcohol/day for at least one year
- Pregnant women
- Subjects not giving consent
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00405301
Start Date
December 1 2006
End Date
December 1 2008
Last Update
February 16 2012
Active Locations (2)
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1
Sri Venkateswara Institute of Medical Sciences
Tirupati, Andhra Pradesh, India, 517507
2
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029