Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Primary Biliary Cholangitis (pbc)
• Age: Between 18 Year(s) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Must have a confirmed prior diagnosis of PBC
  2. Evidence of cirrhosis
  3. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
  4. Subjects must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

  
  

You may not be eligible for this study if the following are true:

• 1. Prior use of seladelpar greater than 26 weeks and within 52 weeks of Screening
  2. History of liver transplantation or actively listed for cadaveric or planned living donor transplant. Subjects on the transplant list despite relatively early-stage disease (e.g., per region guidelines) may be eligible as long as other exclusion criteria are not met
  3. Decompensated cirrhosis, as defined by the history of any one of the following conditions:
     • Ascites requiring treatment
     • Esophageal or gastric varices with a history of bleeding or requiring endoscopic therapy
     • Hepatic encephalopathy (as defined by a West Haven score =2 and requiring hospitalization and/or treatment with lactulose or rifaximin)
     • Spontaneous bacterial peritonitis confirmed by WBC count, differential, and/or inoculation of aerobic and anaerobic blood culture bottles
     • Hepatorenal syndrome (Type I or II)
     • Transjugular intrahepatic portosystemic shunt placement and/or have undergone portacaval shunting
     • Known hepatic venous pressure gradient >12 mmHg
  4. Portal vein thrombosis
  5. Hospitalization for liver-related complication within 12 weeks of Screening
  6. CP-C cirrhosis (i.e., CP score: =10)
  7. History or presence of other concomitant liver diseases including any of the following:
     • Evidence of acute viral hepatitis A
     • Hepatitis B virus infection (acute or chronic)
     • Hepatitis C virus (HCV) infection defined as the presence of HCV ribonucleic acid
     • Primary sclerosing cholangitis confirmed by cholangiographic findings
     • Alcoholic liver disease
     • Alpha-1-antitrypsin deficiency
     • Nonalcoholic steatohepatitis confirmed by liver biopsy
     • Gilbert's Syndrome with elevated TB, or conditions with significant hemolysis
     • Hemochromatosis
     • Hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms; any history, current evidence, or high suspicion is exclusionary
  8. History of planned Roux-en-Y gastric bypass surgery
  9. History of malignancy diagnosed or treated, within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to Screening
  10. Known history of human immunodeficiency virus (HIV) or positive antibody test at Screening
  11. Clinically important alcohol consumption, defined as >14 drinks per week for women and >21 drinks per week for men, or inability to quantify alcohol intake reliably
  12. History of known or suspected clinically significant hypersensitivity to seladelpar or any of its components
  13. Initiation or dose adjustment of UDCA within 12 weeks of Screening
  14. Treatment with obeticholic acid or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, or saroglitizar) within 6 weeks prior to Screening
  15. Treatment with colchicine, methotrexate, azathioprine, or long-term use of systemic corticosteroids (>2 weeks) within 8 weeks prior to Screening. Up to 5 mg prednisone or equivalent for a non-hepatic, stable co-morbidity is allowed with approval from the Medical Monitor
  16. Any long-term treatment with immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti- tumor necrosis factor (TNF), or other immunosuppressive biologics) within the past 6 months prior to Screening
  17. Dose-adjustment of antipruritic drugs (e.g., cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) within 1 month prior to Screening
  18. For females, pregnancy or breastfeeding
  19. Active coronavirus disease 2019 (COVID-19) infection during the screening period