Short Course Steroids in Alcohol Associated Hepatitis

NCT06919458 | Recruiting Phase 3

• 2 other identifiers: SAAH-01CTRI/2025/03/083463
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

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 the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids. The investigators have recently demonstrated that tapering prednisolone over 4 weeks reduces the risk of infections at day 90. However, the investigators wanted to test whether the reduction in the duration of therapy would provide a similar benefit as tapering the dose of prednisolone. Therefore, the investigators planned to assess the impact of a shorter duration of prednisolone on outcomes, including the incidence of infections, survival and adverse events. One group will receive 7 days of prednisolone followed by a placebo for the next seven days, and the other group will receive 40 mg of prednisolone for 14 days. Prednisolone will be stopped in case of non-response and/or adverse events to the drug. All infections will be diagnosed by an ID specialist who is blind to the allocated group.

Conditions

Alcoholic Hepatitis

Keywords

STASH II; corticosteroids; infections

Outcome Measures

Primary Outcomes (1)

• Proportion of participants developing infection in each group

  Infections will be assessed as defined priori. Infections will be compared among patient who respond to steroids and who do not.

  at day 28 and 90

Secondary Outcomes (6)

• Mortality rate among the two groups

  day 90

• Effiacy of prednisolone in each group

  day 28 and 90

• Number of steroid responders in each group

  day 7

• compare proportion of patients requiring readmission

  day 90

• compare incidence of acute kidney injury (AKI) In each group

  day 90

Study Arms (2)

Prednisolone dose of 40mg/day for 7 days

ACTIVE COMPARATOR

Participants satisfying the inclusion criteria will be randomly allocated. Participants in Group A will receive prednisolone dose of 40 mg/day for 7 days after which the participants will recieve seven days of prednisolone 40 mg/day for next 7 days provided they had responded on day 7 based on Lille score

Drug: Prednisolone 40 mg

Prednisolone dose of 40mg/day for 14 days

ACTIVE COMPARATOR

Participants satisfying the inclusion criteria will be randomly allocated. Participants in Group B will receive prednisolone dose of 40 mg/day for 14 days only if they respond to on day 7 based on Lille score

Drug: Prednisolone 40 mg

Interventions

Prednisolone 40 mg DRUG

Patients will be screened for infection till 90 days from the day of initiation of prednisolone. the three patient arms will be compared for severity scores of the disease, rate and severity of infections, diabetic control, post-treatment outcomes, and mortality.

Prednisolone dose of 40mg/day for 14 days; Prednisolone dose of 40mg/day for 7 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 and procalcitonin \< 1 ng/ml.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Mahatma Gandhi Medical College: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator
• Kalinga Institute of Medical Sciences, Bhubaneswar: collaborator
• Apollo Gleneagles Hospitals, Kolkata: collaborator

Study Sites (2)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

AIG

Hyderabad, Telangana, 500035, India

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic; Infections

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

ANAND KULKARNI V DR. ANAND V KULKARNI, SENIOR CONSULTANT

CONTACT

04042444222; anandvk90@gmail.com

Sridevi prasanna daparti, DR

CONTACT

04042444222; deviprasanna9804@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: ID specialist will be blinded to the trial group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 7, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 1.1.2027 to 1.1.2029
• Access Criteria: By mailing the specified protocol and ethics approval, any scientist can access the data by mailing to the primary investigator

Locations

IN (2)