NCT01677871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

August 30, 2012

Last Update Submit

December 16, 2013

Conditions

Chronic Liver Disease With Tuberclosis

Outcome Measures

Primary Outcomes (1)

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

    6 and 9 months

Secondary Outcomes (3)

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

    6 and 9 months

  • 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

    6 and 9 months

Study Arms (4)

2HRZE/4HR

EXPERIMENTAL

Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months

Drug: 2HRLE/4HR

2HRLE/4HR

ACTIVE COMPARATOR

Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months

Drug: 2HRZE/4HR

9HLE

EXPERIMENTAL

Isoniazid+ Levofloxacin+ Ethambutol for 9 months

Drug: 9RLE

9RLE

ACTIVE COMPARATOR

Rifampicin + Levofloxacin+ Ethambutol for 9 months

Drug: 9HLE

Interventions

2HRZE/4HRDRUG

Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months

2HRLE/4HR
2HRLE/4HRDRUG

Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months

2HRZE/4HR
9HLEDRUG

Isoniazid+ Levofloxacin+ Ethambutol for 9 months

9RLE
9RLEDRUG

Rifampicin + Levofloxacin+ Ethambutol for 9 months

9HLE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Study Officials

  • Dr Naveen Kumar, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Naveen Kumar, MD

CONTACT

011-46300000naveenilbsdelhi@gmail.com

Dr Ankit Bhardwaj

CONTACT

011-46300000bhardwaj.ankit3@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

IN(1)