Short course of steroids for treating severe alcohol-related liver disease
Seven Day Versus Fourteen-day Corticosteroid in Patients With Severe Alcohol -Associated Hepatitis- A Double Blind Randomized Controlled Trail (STASH II)
PHASE3 · Asian Institute of Gastroenterology, India · NCT06919458
This study is testing if a shorter 7-day course of steroids can help people with severe alcohol-related liver disease just as well as the standard 14-day treatment while reducing the risk of infections.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India (other) |
| Locations | 2 sites (Hyderabad, Telangana and 1 other locations) |
| Trial ID | NCT06919458 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a shorter duration of prednisolone treatment in patients with severe alcohol-associated hepatitis (AAH). Participants will be divided into two groups: one receiving 7 days of prednisolone followed by a placebo, and the other receiving a standard 14-day course of prednisolone. The study aims to assess outcomes such as infection rates, survival, and adverse events associated with the different treatment durations. The goal is to determine if a shorter steroid regimen can provide similar benefits while potentially reducing the risk of infections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with severe alcohol-associated hepatitis, indicated by a MELD score greater than 21 or a Maddrey's Discriminant Function score greater than 32.
Not a fit: Patients with active infections, significant kidney issues, or other severe liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment protocols for patients with severe alcohol-associated hepatitis, reducing complications and enhancing survival rates.
How similar studies have performed: Previous studies have shown that corticosteroids can be beneficial for severe alcohol-associated hepatitis, but this specific approach of shortening the treatment duration is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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
Where this trial is running
Hyderabad, Telangana and 1 other locations
- AIG Hospitals — Hyderabad, Telangana, India (RECRUITING)
- AIG — Hyderabad, Telangana, India (RECRUITING)
Study contacts
- Study coordinator: ANAND KULKARNI V DR. ANAND V KULKARNI, SENIOR CONSULTANT
- Email: anandvk90@gmail.com
- Phone: 04042444222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcoholic Hepatitis, STASH II, corticosteroids, infections