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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

This study is currently recruiting participants.
Verified August 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01677871
First received: August 30, 2012
Last updated: March 30, 2013
Last verified: August 2012
History of Changes
  Purpose

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.

Condition Intervention
Chronic Liver Disease With Tuberclosis
 Drug: 2HRZE/4HR
Drug: 2HRLE/4HR
Drug: 9HLE
Drug: 9RLE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen. [ Time Frame: 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis, [ Time Frame: 6 and 9 months ] [ Designated as safety issue: No ]
  • Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity. [ Designated as safety issue: No ]
  • Survival [ Time Frame: 6 and 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Active Comparator: 2HRLE/4HR
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
 Drug: 2HRZE/4HR
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
Experimental: 9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
 Drug: 9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
Active Comparator: 9RLE
Rifampicin + Levofloxacin+ Ethambutol for 9 months
 Drug: 9HLE
Isoniazid+ Levofloxacin+ Ethambutol for 9 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677871

Contacts
Contact: Dr Naveen Kumar, MD 011-46300000 naveenilbsdelhi@gmail.com
Contact: Dr Ankit Bhardwaj 011-46300000 ext 1032 bhardwaj.ankit3@gmail.com

Locations
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Ankit Bhardwaj     011-46300000     bhardwaj.ankit3@gmail.com    
Contact: Dr Ankit Bhardwaj     011-46300000 ext 1032     bhardwaj.ankit3@gmail.com    
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Naveen Kumar, MD Institute of Liver and Biliary Sciences
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01677871     History of Changes
Other Study ID Numbers: ILBS-ATT-01
Study First Received: August 30, 2012
Last Updated: March 30, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Liver Diseases
Tuberculosis
Digestive System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antitubercular Agents
Ethambutol
Rifampin
Ofloxacin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antibiotics, Antitubercular
Leprostatic Agents

ClinicalTrials.gov processed this record on June 18, 2013