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

Primary Purpose

Chronic Liver Disease With Tuberclosis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
2HRZE/4HR
2HRLE/4HR
9HLE
9RLE
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Liver Disease With Tuberclosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

2HRZE/4HR

2HRLE/4HR

9HLE

9RLE

Arm Description

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

Outcomes

Primary Outcome Measures

Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.

Secondary Outcome Measures

Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
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

Full Information

First Posted
August 30, 2012
Last Updated
December 16, 2013
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01677871
Brief Title
Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
Official Title
Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease With Tuberclosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2HRZE/4HR
Arm Type
Experimental
Arm Description
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
Arm Title
2HRLE/4HR
Arm Type
Active Comparator
Arm Description
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
Arm Title
9HLE
Arm Type
Experimental
Arm Description
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
Arm Title
9RLE
Arm Type
Active Comparator
Arm Description
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Intervention Type
Drug
Intervention Name(s)
2HRZE/4HR
Intervention Description
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
Intervention Type
Drug
Intervention Name(s)
2HRLE/4HR
Intervention Description
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
Intervention Type
Drug
Intervention Name(s)
9HLE
Intervention Description
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
Intervention Type
Drug
Intervention Name(s)
9RLE
Intervention Description
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Primary Outcome Measure Information:
Title
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
Time Frame
6 and 9 months
Secondary Outcome Measure Information:
Title
Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
Time Frame
6 and 9 months
Title
Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.
Title
Survival
Time Frame
6 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Naveen Kumar, MD
Phone
011-46300000
Email
naveenilbsdelhi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Ankit Bhardwaj
Phone
011-46300000
Ext
1032
Email
bhardwaj.ankit3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Naveen Kumar, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Ankit Bhardwaj
Phone
011-46300000
Email
bhardwaj.ankit3@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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