NCT01677871

Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease

Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease With Tuberclosis

Interventions

Type	Name	Description
DRUG	2HRZE/4HR	Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
DRUG	2HRLE/4HR	Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
DRUG	9HLE	Isoniazid+ Levofloxacin+ Ethambutol for 9 months
DRUG	9RLE	Rifampicin + Levofloxacin+ Ethambutol for 9 months

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-09-03
• Last updated: 2013-12-17

Locations

1 site across 1 country: India