Physician

Studies: Physicians

NASH Study Basics

  1. Age 18+, BMI ≥ 18, able to read and understand English (with exception of Spanish).
  2. Dx of Fatty Liver/NASH via labs, US, FS, LBx.
  3. Stable T2DM AEB Hgb A1c ≤ 9.5
  4. Females: Two effective forms of birth control prior to screening and continuing past last study dose. Males: must use condoms continuing past last study dose.
  5. NO Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females X last 3 months or use of controlled substances without an active prescription.
  6. NO Unstable CV disease within 6 months, uncontrolled HTN, hypercoagulable condition, chronic kidney disease, or history of venous or arterial thromboembolic disease.
  7. NO malignancy within last 5 years or active, serious disease with likely life expectancy < 2 years.
  8. NO prior or planned weight reduction surgery in last 5 years or weight loss ≥5% in last 6 months.
  9. NO pregnant or breast-feeding females.
  10. NO evidence of hepatic decompensation/cirrhosis or other forms of liver disease to include autoimmune, viral, drug-induced liver disease, and alcoholic liver disease.

 

*More intensive criteria are involved. Please remember these are basic criteria.

 

Cirrhosis Study Basics

  1. Same criteria as above except diagnostics showing cirrhosis due to NASH: LBx OR clinical diagnosis (e.g. PLTs < 150, AST >ALT, and either nodular liver surface on imaging or splenomegaly).
  2. Compensated cirrhosis: no history of or presence of clinically evident ascites, variceal hemorrhage, or encephalopathy, and on no medications to treat these complications

OR

Decompensated cirrhosis with no more than 1 prior significant decompensating event that occurred at least 3 months prior to Day 1 and is on stable medication for the event for at least 3 months prior to Day 1

  1. NO evidence of severe decompensation

*More intensive criteria are involved. Please remember these are basic criteria.

Primary Biliary Cholangitis Basics

  1. Age 18+, BMI ≥ 18, able to read and understand English (with exception of Spanish).
  2. Dx of PBC via two criteria: Hx of AP > 200, + AMA or PBC-specific antinuclear antibodies, LBx consistent with PBC.
  3. On a stable/recommended dose of UDCA or intolerant to UDCA.
  4. Females: effective BC + barrier method prior to screening and continuing past last dose. Males: barrier method + female partner must use a second effective BC method.
  5. NO other forms of liver disease to include autoimmune, viral, and alcoholic liver disease.
  6. NO diseases/conditions that would compromise the subject or study (e.g. CA on active tx).

*More intensive criteria are involved. Please remember these are basic criteria.

Primary Sclerosing Cholangitis Basics

  1. Age 18+, BMI ≥ 18, able to read and understand English (with exception of Spanish).
  2. Dx of PSC based on: cholangiogram (MRCP, ERCP or PTC); LBx; AP > 200.
  3. For those on UDCA, the dose of UDCA must have been stable for at least 12 months before screening.
  4. Females: effective BC + barrier method prior to screening and continuing past last dose. Males: barrier method + female partner must use a second effective BC method.
  5. NO diseases/conditions that would compromise the subject or study (e.g. CA on active tx).
  6. NO other forms of liver disease to include autoimmune, viral, and alcoholic liver disease.

*More intensive criteria are involved. Please remember these are basic criteria.

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