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 given written informed consent
  2. 18 to 75 years old (inclusive)
  3. Male or female with a diagnosis of PBC
  4. UDCA for the 12 months prior to screening (with stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
  5. 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.

  
  

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

• 1. Previous exposure to seladelpar (MBX-8025)
  2. Clinically important hepatic decompensation, including the following:
     1. History of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score =12.
     2. Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (eg, transjugular intrahepatic portosystemic shunt placement), ascites, or hepatic encephalopathy
     3. Presence or history of cirrhosis with complications, including spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome
  3. Other chronic liver diseases:
     1. Primary sclerosing cholangitis
     2. History of alcoholic liver disease
     3. History or clinical evidence of alpha-1-antitrypsin deficiency
     4. History of biopsy confirmed NASH
     5. History or evidence of Gilbert’s syndrome
     6. History or evidence of hemochromatosis
     7. Hepatitis B (acute or chronic)
     8. History, evidence, or high suspicion of hepatobiliary malignancy
  4. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
  5. Clinically important alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to quantify alcohol intake reliably
  6. History of malignancy diagnosed or treated, active or 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
  7. History of drug abuse
  8. Treatment with obeticholic acid or fibrates (eg, bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 6 weeks prior to screening
  9. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening. Up to 5 mg/day prednisone or equivalent for a nonhepatic, stable comorbidity is allowed with approval from the Medical Monitor, as is topical or inhaled corticosteroid use.
  10. Initiation or dose adjustment of anti-pruritic drugs (eg, cholestyramine, naltrexone, rifampicin, sertraline, or any investigational therapeutic) within 1 month prior to screening
  11. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics) within 6 months prior to screening
  12. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
  13. Pregnancy or plans to become pregnant, or breastfeeding