Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis
1 other identifier
interventional
150
1 country
1
Brief Summary
Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Prednisolone (40 mg/day) given orally should be considered to improve 28-day mortality in patients with severe AH. Abstinence is key to long-term survival. According to current protocol, we discontinue the treatment after 28 days but only 15 % patient is achieving the DF \< 32 after 28 days of treatment. The aim of this study is to evaluate the role of extended low dose prednisolone (10mg) in achieving remission by day-90 in steroid responsive severe alcoholic hepatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2023
CompletedStudy Start
First participant enrolled
November 25, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2025
CompletedDecember 4, 2023
October 1, 2023
1.3 years
November 16, 2023
December 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMT
90 days
Secondary Outcomes (4)
Changes in the liver disease severity parameters like CTP, MELD-Na, DF, by extending the low dose steroids by 2 months in the study group compared with the control group.
90 days
Number of patients with SAH achieving 90 day transplant-free survival between the two groups.
90 day, 180 day
New onset infections, diabetes
90 days
90 day readmission rates
90 days
Study Arms (2)
Extended Steroid Therapy
EXPERIMENTAL10mg of prednisolone plus standard medical therapy for 60 days. SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision
Placebo group
ACTIVE COMPARATORStandard treatment plus placebo that the patient would receive included in the trial. SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision
Interventions
10mg of prednisolone plus standard medical therapy for 60 days
IV Albumin, Diuretics, Multi vitamins as per clinicians decision
Eligibility Criteria
You may qualify if:
- Persistence of mDF \> 32 at day 28 of steroids.
You may not qualify if:
- Active infection
- Uncontrolled sugars
- No consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2023
First Posted
December 4, 2023
Study Start
November 25, 2023
Primary Completion
February 27, 2025
Study Completion
February 27, 2025
Last Updated
December 4, 2023
Record last verified: 2023-10