| CTRI Number |
CTRI/2025/01/078997 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mycophenolate Mofetil (drug) Versus Steroid Therapy in Alcoholic Hepatitis (liver disease). |
|
Scientific Title of Study
|
Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ananthu SJ Narayan |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
ananthunarayansj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shasthry S M |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shasthry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shasthry S M |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
shasthry@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj,New Delhi-110070. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananthu SJ Narayan |
Institute of Liver and Biliary Sciences |
Room No. 3368, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
ananthunarayansj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K701||Alcoholic hepatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mycophenolate mofetil |
Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days. |
| Comparator Agent |
Steroid prednisolone |
Oral steroid at a dose of 40 mg for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18-70 years.
2. Diagnosis of Alcoholic hepatitis based on NIAAA criteria
3. MELD 20-35
4. Willing to follow up |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 Outcome
|
| Outcome |
TimePoints |
| To assess the impact of MMF versus steroid therapy on disease severity in patients with alcoholic hepatitis at 28 days and 90 days |
28 & 90 days |
| To investigate the safety profile of MMF versus steroid therapy in patients with alcoholic hepatitis, including adverse events and tolerability. |
28 & 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 & 90 days |
| To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies. |
28 & 90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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.
|