SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
This study will evaluate the safety, feasibility, and preliminary effects of S-adenosyl-L-methionine (SAMe) compared with placebo in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis. Investigators will assess whether treatment is associated with changes in liver-related clinical measures, biologic markers, and other study outcomes relevant to disease progression. The goal of this study is to generate early data to determine whether SAMe should be studied further as a potential therapeutic strategy in patients with MASLD cirrhosis.
Eligibility criteria
Qualifiers
individuals 18 years old or above.
Understand the study procedures and able to provide informed consent.
Current weekly intake of alcohol <210 g (7.41 oz) for male or weekly intake of alcohol <140 g (4.76 oz) for female, [1 oz/30 mL of alcohol is present in one 12 oz/360 mL beer, 4 oz/120 mL glass of wine, and a 1oz/30 mL measure of 40 proof (20%) alcohol]
Patient had imaging for HCC screening (Ultrasound or MRI or CT) within 3 months prior to screening.
Disqualifiers
Confirmed diagnosis of HCC prior to screening, any suspicious nodules identified prior or during screening must be followed with documentation of HCC negative confirmed prior to randomization.
History of other causes of liver disease, including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (primary biliary cholangitis, primary sclerosing cholangitis, or autoimmune hepatitis), drug-induced hepatotoxicity, Wilson's disease, iron overload, or alpha-1-antitrypsin deficiency.
Most recent serum creatinine >1.5 mg/dl within 3 months prior to screening.
Active infection with positive urine culture, blood culture, or pneumonia at screening.
Trial design
Treatments tested in this trial
- S-adenosyl-L-methionine (SAMe)
- Placabo
Treatment groups
94 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov