Status:
RECRUITING
Short Course Steroids in Alcohol Associated Hepatitis
Lead Sponsor:
Asian Institute of Gastroenterology, India
Collaborating Sponsors:
Mahatma Gandhi Medical College
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol related liver disease (ARLD), with high morbidity and mortality. Currently, corticosteroids are t...
Detailed Description
Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol-related liver disease (ARLD). Severe alcohol-associated hepatitis (AAH), defined by a Maddrey's D...
Eligibility Criteria
Inclusion
- Patients with AAH aged between 18 and 80 years with a MELD score \>21 and/or mDF \>32 will be included.
- Patients with infection at baseline will be included if they have controlled infection defined as afebrile for at least 48 hours, sterile cultures and procalcitonin \< 1 ng/ml.
Exclusion
- Age \< 18 years, \> 80 years
- Active Infection
- Persistent acute kidney injury (creatinine \>1.5 mg/dl) or chronic kidney disease
- Recent/ongoing bleed
- Active peptic ulcer disease
- Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction
- Patients with concomitant other liver diseases including hepatitis B, C
- Patients with HIV
- Uncontrolled diabetes mellitus
- Patients on pentoxifylline or NAC
- Patients who are unwilling
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2026
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06919458
Start Date
April 7 2025
End Date
April 8 2026
Last Update
April 17 2025
Active Locations (2)
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1
AIG Hospitals
Hyderabad, Telangana, India, 500032
2
AIG
Hyderabad, Telangana, India, 500035