MedTrace Logo

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

NCT01677871 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-12-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr Naveen Kumar, MD · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677871 on ClinicalTrials.gov