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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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Liver Disease With Tuberclosis

Intervention: 2HRZE/4HR (Drug); 2HRLE/4HR (Drug); 9HLE (Drug); 9RLE (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Institute of Liver and Biliary Sciences, India

Official(s) and/or principal investigator(s):
Dr Naveen Kumar, MD, Principal Investigator, Affiliation: Institute of Liver and Biliary Sciences

Overall contact:
Dr Naveen Kumar, MD, Phone: 011-46300000, Email: naveenilbsdelhi@gmail.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Dr Naveen Kumar, MD, Phone: 011-46300000, Email: naveenilbsdelhi@gmail.com

Institute of Liver and Biliary Sciences, New Delhi, Delhi 110070, India; Recruiting
Dr Ankit Bhardwaj, Phone: 011-46300000, Email: bhardwaj.ankit3@gmail.com
Dr Ankit Bhardwaj, Phone: 011-46300000, Ext: 1032, Email: bhardwaj.ankit3@gmail.com
Additional Information

Starting date: September 2012
Last updated: December 16, 2013

Page last updated: August 23, 2015

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