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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01677871
First received: August 30, 2012
Last updated: December 16, 2013
Last verified: December 2013
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677871

Locations
India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
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

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: December 16, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Tuberculosis
Liver Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Digestive System Diseases
Ethambutol
Rifampin
Isoniazid
Antitubercular Agents
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 02, 2016