Chronic Liver Disease With Tuberclosis
Conditions
Brief summary
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.
Interventions
DRUG2HRZE/4HR
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
DRUG2HRLE/4HR
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
DRUG9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
DRUG9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males or Females subjects aged 18-75 years. * Subjects with chronic liver disease (cirrhosis) * Pulmonary or extra-pulmonary tuberculosis. * Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl. * consent and willingness to follow-up
Exclusion criteria
* Serum ALT\>5times upper limit and serum bilirubin \>3 mg/dl. * Renal failure (serum creatinine\>2mg/dl). * Presence of hepatocellular carcinoma * Alcoholic cirrhotic who continue to drink alcohol. * Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity. * Known hypersensitivity to levofloxacin, other quinolones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen. | 6 and 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis, | 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 | 6 and 9 months |
Countries
India
Contacts
Primary ContactDr Naveen Kumar, MD
Backup ContactDr Ankit Bhardwaj
Outcome results
None listed