Is NCT07060638 recruiting in Cleveland, OH?

Yes, NCT07060638 is currently recruiting participants at its Cleveland, OH location. This alcohol-associated hepatitis clinical trial is actively enrolling qualified participants.

How do I join the alcohol-associated hepatitis clinical trial in Cleveland?

To join this clinical trial in Cleveland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cleveland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Alcohol-associated Hepatitis Clinical Trial in Cleveland, OH

About This Alcohol-associated Hepatitis Study in Cleveland

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling whereas tho

Sponsor: Samer Gawrieh

Who Can Participate

Inclusion Criteria

Age ≥18, \<70

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. Ongoing average consumption of \> 40 gm (for females) and \> 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening. C. AST \> 50 IU/L, D. AST: ALT \> 1.5 E. ALT and AST values \< 400 IU/L F. Liver biopsy findings consistent with AH \*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST \< 50 IU/L or \> 400 IU/L, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80, a standard of care liver biopsy will be considered during current hospital admission to confirm AH and exclude competing etiologies.

Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.

Exclusion Criteria

Active listing for liver transplantation before screening

MELD score \<20 or \> 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, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR within one year prior to enrollment

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. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam/gel/film/cream/suppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation.

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 otherwise contraindicate the participant's participation in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT07060638) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alcohol-associated Hepatitis Treatment Options in Cleveland, OH

If you're searching for alcohol-associated hepatitis treatment options in Cleveland, OH, this clinical trial (NCT07060638) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced alcohol-associated hepatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alcohol-associated hepatitis clinical trials near you to find additional studies recruiting in your area.

Alcohol-associated Hepatitis Clinical Trial in Cleveland, OH

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