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Not yet recruitingNCT06789315Updated Jan 23, 2025

Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis

An interventional study of Mycophenolate Mofetil and Prednisone in Alcoholic Hepatitis, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-23.

Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Alcoholic Hepatitis
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults aged 18-70 years.
  2. Diagnosis of Alcoholic hepatitis based on NIAAA criteria
  3. MELD 20-35
  4. Willing to follow up

Exclusion criteria

Exclusion Criteria:

  1. Patients with hepatic/ extra hepatic malignancies
  2. Patients with contraindications to steroids
  3. Patients who are critically ill and are admitted to the ICU
  4. Patient who have severe extra hepatic organ failure
  5. Patients who are HBsAg +, HIV+
  6. If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures
  7. Patients who are on current treatment with prednisone and/or immunosuppressive me.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    mycophenolate mofetil

    Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days.

    Drug: Mycophenolate Mofetil

  • Active comparator
    Steroid prednisolone

    steroid at a dose of 40 mg for 28 days.

    Drug: Prednisone

Interventions

  • DrugMycophenolate Mofetil

    MMF at a dose of 750 mg twice daily for a period of 28 days,

  • DrugPrednisone

    Prednisone at a dose of 40 mg for 28 days.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. MDF Score in alcoholic hepatitis in both the groups at 28 days and 90 days.

    Time frame: 28 days and 90 days.

  2. Number of patients with adverse events in both the groups.

    Time frame: 28 days and 90 days.

  3. 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.

  4. 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.

06

Study locations

1 site
  • Institute of Liver & Biliary Sciences
    New Delhi, Delhi 110070, India
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06789315
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Jan 23, 2025
Start date
Jan 20, 2025 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Jan 23, 2025

Study contacts

Dr Ananthu Narayan, MD
Contact
ananthunarayansj@gmail.com
01146300000
Dr Shasthry SM, DM
Contact
shasthry@gmail.com
01146300000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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