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

Not Applicable

• Conditions: Chronic Liver Disease With Tuberclosis
• Interventions: Drug: 9HLE; Drug: 2HRZE/4HR; Drug: 9RLE; Drug: 2HRLE/4HR

• Registration Number: NCT01677871
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study Start: 2012-09
• Study First Posted: 2012-09-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.	6 and 9 months

Secondary Outcome Measures

Name	Time	Method
Survival	6 and 9 months
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.

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India