Chronic Liver Disease With TuberclosisNCT01677871
Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
A study testing 2HRZE/4HR, 2HRLE/4HR and 9HLE in people with Chronic Liver Disease With Tuberclosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Liver Disease With Tuberclosis
- What is being tested?
- 2HRZE/4HR, 2HRLE/4HR and 9HLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ankit Bhardwaj, 011-46300000, bhardwaj.ankit3@gmail.com
About this study
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
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.
- Conditions
- Chronic Liver Disease With Tuberclosis
- Being tested
- 2HRZE/4HR, 2HRLE/4HR, 9HLE, 9RLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2HRZE/4HRDrug
Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
2HRLE/4HRDrug
Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
9HLEDrug
Isoniazid+ Levofloxacin+ Ethambutol for 9 months
9RLEDrug
Rifampicin + Levofloxacin+ Ethambutol for 9 months
| Study group | Role | What they receive |
|---|---|---|
| 2HRZE/4HR | Experimental | Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months Receives: Drug: 2HRLE/4HR |
| 2HRLE/4HR | Active comparator | Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months Receives: Drug: 2HRZE/4HR |
| 9HLE | Experimental | Isoniazid+ Levofloxacin+ Ethambutol for 9 months Receives: Drug: 9RLE |
| 9RLE | Active comparator | Rifampicin + Levofloxacin+ Ethambutol for 9 months Receives: Drug: 9HLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
Measured: 6 and 9 months
Secondary outcomes (3)
Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
Measured: 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
Measured: 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease With TuberclosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Naveen Kumar, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677871
- Sponsor's protocol ID
- ILBS-ATT-01
- Status last verified
- Dec 2013
- First submitted
- 30 Aug 2012
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01677871
- Acronym / sponsor ID
- ILBS-ATT-01
- Conditions
- Chronic Liver Disease With Tuberclosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2HRZE/4HR | Experimental | Drug: 2HRLE/4HRIsoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months |
| 2HRLE/4HR | Active comparator | Drug: 2HRZE/4HRIsoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months |
| 9HLE | Experimental | Drug: 9RLEIsoniazid+ Levofloxacin+ Ethambutol for 9 months |
| 9RLE | Active comparator | Drug: 9HLERifampicin + Levofloxacin+ Ethambutol for 9 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2HRZE/4HRIsoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months | Drug | 2HRLE/4HR |
| 2HRLE/4HRIsoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months | Drug | 2HRZE/4HR |
| 9HLEIsoniazid+ Levofloxacin+ Ethambutol for 9 months | Drug | 9RLE |
| 9RLERifampicin + Levofloxacin+ Ethambutol for 9 months | Drug | 9HLE |
Primary outcome
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
Time frame: 6 and 9 months
3 secondary outcomes
Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
Time frame: 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
Time frame: 6 and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Naveen Kumar, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2HRZE/4HR, 2HRLE/4HR and 9HLE in people with Chronic Liver Disease With Tuberclosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Naveen Kumar, MD (011-46300000, naveenilbsdelhi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen. (time frame: 6 and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.