Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Anti-TB Drugs Induced Liver Damage

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 developed drug induced liver damage.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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