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Clinical trial

Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis.

ID
Name
ILBS-ALD-03
Description
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 arms
Trial start
2023-11-25
Estimated PCD
2025-02-27
Trial end
2025-02-27
Status
Not yet recruiting
Treatment
Prednisolone
10mg of prednisolone plus standard medical therapy for 60 days
Arms:
Extended Steroid Therapy
Standard Medical therapy
IV Albumin, Diuretics, Multi vitamins as per clinicians decision
Arms:
Extended Steroid Therapy, Placebo group
Placebo
Placebo
Arms:
Placebo group
Size
150
Primary endpoint
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
Eligibility criteria
Inclusion Criteria: 1. Persistence of mDF \> 32 at day 28 of steroids. Exclusion Criteria: 1. Active infection 2. Uncontrolled sugars 3. No consent
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

2 products

1 indication

Organization
Institute of Liver and Biliary Sciences
Product
Prednisolone
Indication
Alcoholic Hepatitis
Product
Placebo