Clinical trial for Alcohol-associated Hepatitis
Official title Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
ClinicalTrials.gov ID: NCT07060638
What this study is testing
What is F-652 (IL-22)?
An investigational fusion protein being studied as a potential treatment for severe alcohol-associated hepatitis. It is designed to deliver IL‑22 activity, which may provide anti‑inflammatory effects in the liver.
Also referred to as IL-22.
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
- This study checks if treating both the liver and alcohol use together leads to better health results than treating the liver alone. It also tests if a new drug called F-652 is safe and works as well as a standard steroid for liver inflammation.
- Who it's for
- People with severe liver inflammation caused by alcohol use and a history of alcohol use disorder.
- What's involved
- Participants will get liver treatment (either a new drug or a standard steroid) plus either daily medication and counseling for alcohol or standard advice and referrals.
- Time commitment
- The study lasts about 6 months and involves regular visits to check on liver health and alcohol use.
- Phase 2: a mid-size study of how well it works
- 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 70
You may be able to join if
- Age ≥18, \<70
- MELD 20-35
- Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A.
- Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.
You likely can't join if
- Active listing for liver transplantation before screening
- MELD score \ 35
- Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- Progressive hemodynamic compromise requiring intravenous pressors
- Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam)
- Renal failure defined by estimated GFR (CKD-EPI) \<35 mL/min.
See the full eligibility criteria
- Age ≥18, \<70
- MELD 20-35
- Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks B.
- Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.
- Active listing for liver transplantation before screening
- MELD score \ 35
- Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- Progressive hemodynamic compromise requiring intravenous pressors
- Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam)
- Renal failure defined by estimated GFR (CKD-EPI) \<35 mL/min.
- Clinically active C. diff infection
- Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease)
- History or presence of cancer (including hepatocellular carcinoma) other than non-melanoma skin cancer
- Prior exposure to systemic corticosteroid (glucocorticoid) or TNF-alpha inhibitors for more than 4 days within the previous 30 days prior to screening, specifically for the treatment of sAH.
- Clinically significant pancreatitis- abdominal pain, elevated lipase (\> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan
- Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to \< 65 mmHg
- Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator
- Uncontrolled mental illness as determined by the study investigator
- Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, people with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and people with history of HCV will...
- Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days via patient report or medical chart review.
- Uncontrolled diabetes mellitus with A1c \> 9
- Pregnancy or breastfeeding
- Known allergy or intolerance to therapeutic agents to be tested
- Unwillingness to stop alcohol use and to undergo AUD treatment
- Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication.
- Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may...
The study team makes the final eligibility decision.
Where it is enrolling
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Indianapolis, Indiana, United States; Louisville, Kentucky, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States; Dallas, Texas, United States; Richmond, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.