NCT06789315

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 13, 2025

Last Update Submit

January 17, 2025

Conditions

Alcoholic Hepatitis

Outcome Measures

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

    28 days

Secondary Outcomes (4)

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

    28 days and 90 days.

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

    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

    28 days and 90 days.

  • To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies.

    28 days and 90 days.

Study Arms (2)

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.

Drug: Mycophenolate Mofetil

Steroid prednisolone

ACTIVE COMPARATOR

steroid at a dose of 40 mg for 28 days.

Drug: Prednisone

Interventions

Mycophenolate MofetilDRUG

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

mycophenolate mofetil
PrednisoneDRUG

Prednisone at a dose of 40 mg for 28 days.

Steroid prednisolone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Mycophenolic AcidPrednisone

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Dr Ananthu Narayan, MD

CONTACT

01146300000ananthunarayansj@gmail.com

Dr Shasthry SM, DM

CONTACT

01146300000shasthry@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 23, 2025

Study Start

January 20, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations

IN(1)