A Study of the Safety, Tolerability, and Effectiveness of GS-9674 for Adults with Primary Sclerosing Cholangitis without Cirrhosis

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of GS-9674 in adults who have primary sclerosing cholangitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of PSC based on cholangiogram (magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiogram (PTC)) within the previous 12 months
  • Serum alkaline phosphatase (ALP) > 1.67 x upper limit of the normal range (ULN)
  • If on ursodeoxycholic acid (UDCA), dose must have been stable for at least 12 months prior to screening through the end of treatment
  • If not on UDCA, then no UDCA use for at least 12 months before screening through the end of treatment
  • Screening FibroSURE/FibroTest® < 0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis
    • With Gilbert's syndrome or hemolysis, FibroSURE/FibroTest® will be calculated using direct bilirubin instead of total bilirubin

Exclusion Criteria

  • Alanine aminotransferase (ALT) > 10 x ULN
  • Total bilirubin > 2 x ULN
  • International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
  • Small-duct PSC (histologic evidence of PSC with normal bile ducts on cholangiography)
  • Other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions
  • Ascending cholangitis within 60 days of screening
  • Presence of a percutaneous drain or bile duct stent
  • Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
  • Cirrhosis of the liver as defined by any of the following
    • Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
    • Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
    • Liver stiffness > 14.4 kPa by FibroScan
  • Current, active inflammatory bowel disease (IBD) defined as a partial Mayo score of > 1 and/or a score on the Rectal Bleeding domain > 0.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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