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
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