During the Study: * Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required * The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients. * Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment. * Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required. * The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGSuccessful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
Time frame: 6 and 9 months
Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
Time frame: 6 and 9 months
Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.
Survival
Time frame: 6 and 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.