Alcoholic HepatitisNCT06355726
Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function
A study testing Plasma Exchange and Standard Medical Treatment in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Plasma Exchange and Standard Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 9 Apr 2024to 28 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Severe alcoholic hepatitis with DF>80< 120 or MELD >30
- No liver transplant option available in near future(for atleast 1 month)
- Patient able to bear the cost of Plasma exchange by himself/herself
Who cannot join
- Active sepsis
- S creatinine >1.5mg/dl
- Chronic kidney disease
- Pregnancy
- HCC or any other malignancy
- Active Bleeding
Show all 10Show fewer
- Allergic to replacement fluid (FFP) in TPE
- Severe Hypocalcemia (<7.6 mg/dl)
- Failure to give consent
- Financial issues to bear cost of Plasma exchange
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Jitendra Kumar Singh, MD, 01146300000, jitendra2602kc@gmail.com
About this study
Official title: Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function : A Randomised Controlled Trial
Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.[1] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.[2,8] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation.
Read the detailed description
Hypothesis:wehypothesise that the early treatment with therapeutic plasma exchange in alcoholic hepatitis patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.
Aim:
To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis
Methodology:
Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD ,if there is no options of Liver transplant in near future ,1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEX.He/she will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefited.Patients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly.
Control group will be administered SMT only.Case are those who get both SMT and PLEX. SMT involved empirical antibiotics as per treating physician,multivitamins,albumin. Hepatic encephalopathy (HE) will be treated with lactulose and rifaximin. Ascites with diuretics if not contraindicated because of renal insufficiency or HE. All patients will receive salt restricted, high protein diet (1.5 g/kg of proteins) either enterally/parenterally in addition to thiamine and multivitamins,35 to 45 kcal /kg .
Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure
Study population:
- Age - 18-60 years
- Patients with steroid ineligible(DF > 80< 120,MELD > 30) severe alcoholic hepatitis(Bili > 5 ,INR > 1.5)
Study design: Randomised controlled study done at Department of Hepatology,Institute of Liver and Biliary Sciences,NewDelhi,India.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Plasma Exchange, Standard Medical Treatment
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma ExchangeBiological
Plasma exchange session will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| PLEX with SMT | Experimental | 3 sessions to 5 max, alternate day with SMT Receives: Biological: Plasma Exchange; Other: Standard Medical Treatment |
| SMT | Active comparator | High calorie intake 35 to 40 Kcal/kg, protein 1.2 to 1.5 g/kg,albumin,antibiotics as required Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transplant free survival at 28 days, 90 days and 180 days.
Measured: 28 days, 90 days and 180 days
Secondary outcomes (10)
Change in total bilirubin and INR as measured by Discriminant Functions
Measured: 28 days, 90 days and 180 days
Number of patients with change in Model for End Stage Liver Disease (MELD)
Measured: 28 days, 90 days and 180 days
Number of patients with change in CTP
Measured: 28 days, 90 days and 180 days
Number of patients with change in LSM,SSM
Measured: 28 days, 90 days and 180 days
Mortality in both groups
Measured: 28 days, 90 days and 180 days
clinical improvement in the form of jaundice as measured by total bilirubin
Measured: 28 days, 90 days and 180 days
clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria
Measured: 28 days, 90 days and 180 days
clinical improvement in the form of ascites as measured by ICA criteria.
Measured: 28 days, 90 days and 180 days
Frequency of decompensation events on follow up period
Measured: 28 days, 90 days and 180 days
Adverse events during plasma exchange
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start9 Apr 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355726
- Sponsor's protocol ID
- ILBS-Alcoholic Hepatitis-03
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function : A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06355726
- Acronym / sponsor ID
- ILBS-Alcoholic Hepatitis-03
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- 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.
Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.[1] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.[2,8] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation.
Detailed description
Hypothesis:wehypothesise that the early treatment with therapeutic plasma exchange in alcoholic hepatitis patients might improve overall survival in carefully selected patients by removing cytokines, chemokines and toxic substances.
Aim:
To compare transplant free survival between plasma exchange therapy and standard medical therapy in severe alcoholic hepatitis
Methodology:
Severe alcoholic hepatitis will be screened for the study and will be managed with SMT initially will be assessed for steroid therapy if becomes ineligible counselled for liver transplant in view of high DF and MELD ,if there is no options of Liver transplant in near future ,1 month will be given option for PLEX but it will be decided by randomisation whether he will get SMT or PLEX.He/she will also be told that PLEX is not a approved treatment and is a trial therapy and they may or may not get benefited.Patients Patients who agreed to undergo PLEX then undergo randomisation between PLEX and SMT and allocated in either group accordingly.
Control group will be administered SMT only.Case are those who get both SMT and PLEX. SMT involved empirical antibiotics as per treating physician,multivitamins,albumin. Hepatic encephalopathy (HE) will be treated with lactulose and rifaximin. Ascites with diuretics if not contraindicated because of renal insufficiency or HE. All patients will receive salt restricted, high protein diet (1.5 g/kg of proteins) either enterally/parenterally in addition to thiamine and multivitamins,35 to 45 kcal /kg .
Cases will be administered SMT with Plasma exchange session which will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure
Study population:
- Age - 18-60 years
- Patients with steroid ineligible(DF > 80< 120,MELD > 30) severe alcoholic hepatitis(Bili > 5 ,INR > 1.5)
Study design: Randomised controlled study done at Department of Hepatology,Institute of Liver and Biliary Sciences,NewDelhi,India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLEX with SMT | Experimental | Biological: Plasma Exchange, Other: Standard Medical Treatment3 sessions to 5 max, alternate day with SMT |
| SMT | Active comparator | Other: Standard Medical TreatmentHigh calorie intake 35 to 40 Kcal/kg, protein 1.2 to 1.5 g/kg,albumin,antibiotics as required |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 60 years
- Severe alcoholic hepatitis with DF>80< 120 or MELD >30
- No liver transplant option available in near future(for atleast 1 month)
- Patient able to bear the cost of Plasma exchange by himself/herself
Key exclusion criteria (10 listed)
- Active sepsis
- S creatinine >1.5mg/dl
- Chronic kidney disease
- Pregnancy
- HCC or any other malignancy
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 |
|---|---|---|
| Plasma ExchangePlasma exchange session will be done on alternate day to a maximum of 5 sessions. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session,no improvement in clinical condition and Intolerant to PLEX procedure | Biological | PLEX with SMT |
| Standard Medical TreatmentStandard Medical Treatment | Other | PLEX with SMT, SMT |
Primary outcome
Liver transplant free survival at 28 days, 90 days and 180 days.
Time frame: 28 days, 90 days and 180 days
10 secondary outcomes
Change in total bilirubin and INR as measured by Discriminant Functions
Time frame: 28 days, 90 days and 180 days
Number of patients with change in Model for End Stage Liver Disease (MELD)
Time frame: 28 days, 90 days and 180 days
Number of patients with change in CTP
Time frame: 28 days, 90 days and 180 days
Number of patients with change in LSM,SSM
Time frame: 28 days, 90 days and 180 days
Mortality in both groups
Time frame: 28 days, 90 days and 180 days
clinical improvement in the form of jaundice as measured by total bilirubin
Time frame: 28 days, 90 days and 180 days
clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria
Time frame: 28 days, 90 days and 180 days
clinical improvement in the form of ascites as measured by ICA criteria.
Time frame: 28 days, 90 days and 180 days
Frequency of decompensation events on follow up period
Time frame: 28 days, 90 days and 180 days
Adverse events during plasma exchange
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Exchange and Standard Medical Treatment in people with Alcoholic Hepatitis, 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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 Jitendra Kumar Singh, MD (01146300000, jitendra2602kc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transplant free survival at 28 days, 90 days and 180 days. (time frame: 28 days, 90 days and 180 days). 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 24 Jun 2024.