Alcoholic HepatitisNCT06789315
Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis
A study testing Mycophenolate Mofetil and Prednisone in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Patients with acute alcoholic hepatitis will be identified based on national institute on alcohol abuse and alcoholism (NIAAA) will be identified, MELD score will be calculated, patents with MELD score between 20-35 will be randomized to two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Mycophenolate Mofetil and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years.
- Diagnosis of Alcoholic hepatitis based on NIAAA criteria
- MELD 20-35
- Willing to follow up
Who cannot join
- Patients with hepatic/ extra hepatic malignancies
- Patients with contraindications to steroids
- Patients who are critically ill and are admitted to the ICU
- Patient who have severe extra hepatic organ failure
- Patients who are HBsAg +, HIV+
- If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures
- Patients who are on current treatment with prednisone and/or immunosuppressive me.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ananthu Narayan S J, MD, 01146300000, ananthunarayansj@gmail.com
About this study
Patients with acute alcoholic hepatitis will be identified based on national institute on alcohol abuse and alcoholism (NIAAA) will be identified, MELD score will be calculated, patents with MELD score between 20-35 will be randomized to two groups. Group A (intervention arm) will be receiving Mycofenolate mofetil at a dose of 750 mg twice daily and group B will be receiving steroid as per existing guidelines in a dose of 40 mg per day. Both the groups will be followed up for 90 days with assessment done at 4th, 7th and 28th day. Any significant event in addition will also be noted. Patients in group A will be also be monitored for development of complications like cytopenia due to Mycofenolate mofetil and infections will be monitored in both groups. Steroids will be stopped in the non-responders in group B based on Lille score at 4th and 7th day. The outcome variables of interest and to be measured are survival at 28 days and 90 days, clinical outcomes, including hospitalization and liver related outcomes.
Read the detailed description
Study Design: Single-center, randomized control trial of 1 year duration.
Aim and Objective - To compare the efficacy and safety of Mycophenolate Mofetil (MMF) versus steroid therapy for the treatment of alcoholic hepatitis.
Hypothesis -
- MMF as a first line agent maybe associated with better 28 day and 90-day survival without increasing the risk of infection.
Study population: Patients > 18 years of age.Who are diagnosed as Alcoholic hepatitis based on NIAAA criteria.
- Study design: Randomized double blinded study.
- Study period: 1 year.
- Intervention: Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days, while the control arm will receive steroid at a dose of 40 mg for 28 days. However, based on Lille's score the decision to continue or discontinue steroid will be taken. In case of discontinuation of the drug in either group, they will be provided best medical care and nutrition as salvage therapy.
- Monitoring and assessment: History of all patients with special emphasis to alcoholic history will be taken. The diagnosis of alcoholic hepatitis is confirmed by NIAAA criteria. Liver biopsy will be done in clinically indicated cases. Patients will be classified into acute on chronic liver disease (ACLF) based on APASL criteria. Patients who are eligible for steroid therapy will be randomized to receive steroid or MMF based on computer software. Patients who are in MMF group will receive 750 mg twice daily of MMF. Patients who are in steroid group will receive 40 mg Prednisolone. The study is open label randomized control trial. Lilles score is calculated at 5th day to see for response.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Mycophenolate Mofetil, Prednisone
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMF at a dose of 750 mg twice daily for a period of 28 days,
PrednisoneDrug
Prednisone at a dose of 40 mg for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil | Experimental | Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days. Receives: Drug: Mycophenolate Mofetil |
| Steroid prednisolone | Active comparator | steroid at a dose of 40 mg for 28 days. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis
Measured: 28 days
Secondary outcomes (4)
MDF Score in alcoholic hepatitis in both the groups at 28 days and 90 days.
Measured: 28 days and 90 days.
Number of patients with adverse events in both the groups.
Measured: 28 days and 90 days.
To compare the efficacy of MMF versus steroid therapy in improving long-term (90 day) survival outcomes in patients with alcoholic hepatitis
Measured: 28 days and 90 days.
To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies.
Measured: 28 days 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 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT06789315
- Sponsor's protocol ID
- ILBS-Alcoholic Hepatitis-04
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 23 Jan 2025
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT06789315
- Acronym / sponsor ID
- ILBS-Alcoholic Hepatitis-04
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 23 Jan 2025 (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.
Patients with acute alcoholic hepatitis will be identified based on national institute on alcohol abuse and alcoholism (NIAAA) will be identified, MELD score will be calculated, patents with MELD score between 20-35 will be randomized to two groups. Group A (intervention arm) will be receiving Mycofenolate mofetil at a dose of 750 mg twice daily and group B will be receiving steroid as per existing guidelines in a dose of 40 mg per day. Both the groups will be followed up for 90 days with assessment done at 4th, 7th and 28th day. Any significant event in addition will also be noted. Patients in group A will be also be monitored for development of complications like cytopenia due to Mycofenolate mofetil and infections will be monitored in both groups. Steroids will be stopped in the non-responders in group B based on Lille score at 4th and 7th day. The outcome variables of interest and to be measured are survival at 28 days and 90 days, clinical outcomes, including hospitalization and liver related outcomes.
Detailed description
Study Design: Single-center, randomized control trial of 1 year duration.
Aim and Objective - To compare the efficacy and safety of Mycophenolate Mofetil (MMF) versus steroid therapy for the treatment of alcoholic hepatitis.
Hypothesis -
- MMF as a first line agent maybe associated with better 28 day and 90-day survival without increasing the risk of infection.
Study population: Patients > 18 years of age.Who are diagnosed as Alcoholic hepatitis based on NIAAA criteria.
- Study design: Randomized double blinded study.
- Study period: 1 year.
- Intervention: Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days, while the control arm will receive steroid at a dose of 40 mg for 28 days. However, based on Lille's score the decision to continue or discontinue steroid will be taken. In case of discontinuation of the drug in either group, they will be provided best medical care and nutrition as salvage therapy.
- Monitoring and assessment: History of all patients with special emphasis to alcoholic history will be taken. The diagnosis of alcoholic hepatitis is confirmed by NIAAA criteria. Liver biopsy will be done in clinically indicated cases. Patients will be classified into acute on chronic liver disease (ACLF) based on APASL criteria. Patients who are eligible for steroid therapy will be randomized to receive steroid or MMF based on computer software. Patients who are in MMF group will receive 750 mg twice daily of MMF. Patients who are in steroid group will receive 40 mg Prednisolone. The study is open label randomized control trial. Lilles score is calculated at 5th day to see for response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil | Experimental | Drug: Mycophenolate MofetilIntervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days. |
| Steroid prednisolone | Active comparator | Drug: Prednisonesteroid at a dose of 40 mg for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-70 years.
- Diagnosis of Alcoholic hepatitis based on NIAAA criteria
- MELD 20-35
- Willing to follow up
Key exclusion criteria (7 listed)
- Patients with hepatic/ extra hepatic malignancies
- Patients with contraindications to steroids
- Patients who are critically ill and are admitted to the ICU
- Patient who have severe extra hepatic organ failure
- Patients who are HBsAg +, HIV+
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 |
|---|---|---|
| Mycophenolate MofetilMMF at a dose of 750 mg twice daily for a period of 28 days, | Drug | mycophenolate mofetil |
| PrednisonePrednisone at a dose of 40 mg for 28 days. | Drug | Steroid prednisolone |
Primary outcome
To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis
Time frame: 28 days
4 secondary outcomes
MDF Score in alcoholic hepatitis in both the groups at 28 days and 90 days.
Time frame: 28 days and 90 days.
Number of patients with adverse events in both the groups.
Time frame: 28 days and 90 days.
To compare the efficacy of MMF versus steroid therapy in improving long-term (90 day) survival outcomes in patients with alcoholic hepatitis
Time frame: 28 days and 90 days.
To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies.
Time frame: 28 days and 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycophenolate Mofetil and Prednisone 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 7 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: opening soon, as of the sponsor's last update on 23 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ananthu Narayan, MD (01146300000, ananthunarayansj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis (time frame: 28 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 23 Jan 2025.