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New treatment option for Alcoholic Hepatitis
Official title Short Course Steroids in Alcohol Associated Hepatitis
ClinicalTrials.gov ID: NCT06919458
What this study is testing
What is Prednisolone 40 mg?
Prednisolone 40 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcoholic hepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids.
- Phase 3: a large, late-stage study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- Age \ 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
See the full eligibility criteria
- 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.
- Age \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, Telangana, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, Telangana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.