Acute on Chronic Liver FailureNCT02689245
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
A study testing Tenofovir and Fecal Microbiota Transplantation (FMT) in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- Tenofovir and Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 26 Feb 2016to 13 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
- 18-75 yr both male and female
- Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
- Healthy adult family member of the patient will be taken as a control.
Who cannot join
- Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
- Active gastrointestinal bleeding
- Intracranial bleeding
- Multi-organ failure (>2) on mechanical ventilation
- SOFA score >2
- On high inotropic support
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- Paralytic ileus
- Pregnancy
- Hepatocellular Carcinoma
- Antibiotic,probiotic within last 3 months
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.
Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).
Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Tenofovir, Fecal Microbiota Transplantation (FMT)
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Fecal Microbiota Transplantation (FMT)Drug
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir + Fecal Microbiota Transplantation (FMT) | Experimental | Not described Receives: Drug: Tenofovir; Drug: Fecal Microbiota Transplantation (FMT) |
| Tenofovir | Active comparator | Not described Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival.
Measured: 3 months
Secondary outcomes (13)
Reduction in Hepatitis B Virus DNA level ≥ 2 log.
Measured: 2 weeks
Improvement in MELD (Model for End Stage Liver Disease) score.
Measured: 2 weeks
Improvement in CTP (Child Pugh Turcotte) score.
Measured: 2 weeks
Mortality
Measured: 1 Month
Mortality
Measured: 3 Months
Improvement in hepatic Encephalopathy.
Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
Measured: 7 days
Improvement in International Normalized ratio.
Improvement is defined as International Normalized ratio value within normal limits
Measured: 7 days
Improvement in Total bilirubin.
Improvement is defined as Total bilirubin value within normal limits.
Measured: 7 days
Development of infectious complications during follow up in both groups
Measured: 7,15,30 and 90 days
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
Measured: 7,15,30 and 90 days
Improvement in SOFA (Sequential organ failure assessment) score in both groups.
Measured: 7,15,30 and 90 days
Change in gut microbiome in both the groups
Measured: 0,7,15,30 and 90 days
Assessment of organ failures in both groups
Measured: 7,15,30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start26 Feb 2016
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Juned Ahmad, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689245
- Sponsor's protocol ID
- ILBS-ACLF-007
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2016
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
- ClinicalTrials.gov ID
- NCT02689245
- Acronym / sponsor ID
- ILBS-ACLF-007
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 23 Feb 2016 (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.
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.
Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).
Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir + Fecal Microbiota Transplantation (FMT) | Experimental | Drug: Tenofovir, Drug: Fecal Microbiota Transplantation (FMT) |
| Tenofovir | Active comparator | Drug: Tenofovir |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
- 18-75 yr both male and female
- Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
- Healthy adult family member of the patient will be taken as a control.
Key exclusion criteria (10 listed)
- Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
- Active gastrointestinal bleeding
- Intracranial bleeding
- Multi-organ failure (>2) on mechanical ventilation
- SOFA score >2
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 |
|---|---|---|
| Tenofovir | Drug | Tenofovir, Tenofovir + Fecal Microbiota Transplantation (FMT) |
| Fecal Microbiota Transplantation (FMT) | Drug | Tenofovir + Fecal Microbiota Transplantation (FMT) |
Primary outcome
Transplant free survival.
Time frame: 3 months
13 secondary outcomes
Reduction in Hepatitis B Virus DNA level ≥ 2 log.
Time frame: 2 weeks
Improvement in MELD (Model for End Stage Liver Disease) score.
Time frame: 2 weeks
Improvement in CTP (Child Pugh Turcotte) score.
Time frame: 2 weeks
Mortality
Time frame: 1 Month
Mortality
Time frame: 3 Months
Improvement in hepatic Encephalopathy.
Time frame: 7 days
Improvement in International Normalized ratio.
Time frame: 7 days
Improvement in Total bilirubin.
Time frame: 7 days
Development of infectious complications during follow up in both groups
Time frame: 7,15,30 and 90 days
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
Time frame: 7,15,30 and 90 days
Improvement in SOFA (Sequential organ failure assessment) score in both groups.
Time frame: 7,15,30 and 90 days
Change in gut microbiome in both the groups
Time frame: 0,7,15,30 and 90 days
Assessment of organ failures in both groups
Time frame: 7,15,30 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Acute on Chronic Liver Failure
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Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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 Juned Ahmad, 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 Tenofovir and Fecal Microbiota Transplantation (FMT) in people with Acute on Chronic Liver Failure, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival. (time frame: 3 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 23 Nov 2018.