Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Confirmed diagnosis of primary sclerosing cholangitis (PSC) based on any two of the following three criteria:
* Historical evidence of an elevated alkaline phosphatase (AP) \> upper limit of normal (ULN) from any prior laboratory result
* Liver biopsy consistent with PSC
* Abnormal cholangiography consistent with PSC as measured by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiography (PTC)
2. Individuals must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:
* International Normalized Ratio (INR) ≤ 1.3 (in the absence of warfarin or other anticoagulant therapy)
* Albumin ≥ 3.5 g/dL
3. Patients taking ursodeoxycholic acid (UDCA) will be allowed to enroll if meeting the following criteria:
* Total daily dose of ≤ 20 mg/kg/day
* A minimum of 6 months of stable treatment
* Minimum of 12 weeks off treatment prior to Screening if UDCA is recently discontinued
You may not be if
1. Clinically significant acute or chronic liver disease of an etiology other than PSC
2. Patients with a diagnosis of overlapping autoimmune hepatitis (AIH) and PSC
3. Secondary or immunoglobulin G4 (IgG4) related sclerosing cholangitis
4. Small duct PSC
5. Presence of a cholangiocarcinoma on cholangiography or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or medical monitor
6. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
7. History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms
8. Presumptive or diagnosed acute cholangitis within 12 weeks of Screening and through Day 1
9. Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:
* Historical liver biopsy demonstrating cirrhosis (eg, Ludwig Stage 4 or Ishak Stage 5)
* Current or prior history of decompensated liver disease, including ascites, hepatic encephalopathy, variceal bleeding or other clinical conditions consistent with cirrhosis and/or portal hypertension,
* Liver stiffness \> 14.4 kPa by FibroScan, or
* Combined low platelet count (\< 140 × 10\^3/µL ) with one of the following:
* Serum albumin \< 3.5 g/dL,
* INR \> 1.3 (not due to antithrombotic agent use), or
* Total bilirubin \> ULN
10. Prior or actively listed for liver transplantation
