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

ConditionAlcoholic Hepatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-70 years.

Diagnosis of Alcoholic hepatitis based on NIAAA criteria

MELD 20-35

Willing to follow up

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mycophenolate Mofetil

    Drug

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

  • Prednisone

    Drug

    Prednisone at a dose of 40 mg for 28 days.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: mycophenolate mofetilExperimental treatment 1 intervention
Group B: Steroid prednisoloneActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: