Ensayos clínicos

Inclusion Criteria:

• Age ≥ 18 years
• Willing to provide samples at baseline.
• Cirrhosis - where Cirrhosis is defined as:
  • At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis; OR
• If no liver biopsy, the following imaging + laboratory criteria define cirrhosis for the purposes of this protocol:
  • Evidence on imaging, of stiffness, or of varices according to the MOP, AND;
  • Either: FIB-4 > 2.67 OR platelets < 150 (within 180 days prior to consent or during Screening).

Exclusion Criteria:

• Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
• Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
• Known prior solid organ transplant or bone marrow transplant.
• Current participation in active medication treatment trials at the time of consent for LCN POST.
• Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits.
• Bariatric surgery in the last 180 days prior to consent.
• Known history of fontan procedure-associated liver disease (FALD).
• Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with or prevent follow-up per protocol.
• Current liver-unrelated end-stage organ failures (Dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen, current known active malignancy besides non-melanomatous skin cancer or carcinoma in situ).
• Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent.
• Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis).
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent.
• Documented cardiac cirrhosis.
• Known recent (within the last 365 days) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding.
• Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples).
• Current model for end-stage liver disease (MELD) cut off ≥ 15*.
• Current Child-Turcotte-Pugh (CTP) B or C*.
• Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR).
• Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy*.
• In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) > 2X upper limit of normal (ULN) within 60 days prior to consent or during Screening*.
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent or during Screening*.

*Indicates an exclusion criterion that may depend on laboratory results and other clinical assessments to be ordered during Screening after confirming the participant is otherwise eligible. If the test was performed as standard-of-care in the 60 days prior to consent, it does not need to be re-done for eligibility.  

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.