Phase
Condition
Liver Disorders
Primary Biliary Cholangitis
Gall Bladder Disorders
Treatment
Placebo
BRS201
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP)demonstrating intrahepatic and/or extrahepatic biliary strictures, beading orirregularity consistent with PSC.
ALP > 1.5 times the upper limit of normal (ULN) at screening.
Subject must either be on a stable dose of ursodeoxycholic acid for > 6 months priorto screening or have been discontinued > 4 weeks prior to screening (enrollment ofpatients who are on UDCA will be limited to 60% of all enrolled patients).
Exclusion
Exclusion Criteria:
Anticipated need for liver transplant within one year as determined by Mayo PSC riskscore
Evidence of decompensated liver disease such as variceal bleeding, ascites, orhepatic encephalopathy.
Evidence of advanced liver disease including MELD score > 10, bilirubin > 3.0,platelet count < 100,000; or INR > 1.4
Concomitant chronic liver disease including alcohol related liver disease, chronichepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsindeficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliarycholangitis
Secondary causes of sclerosing cholangitis
Patients who have a confirmed malignancy or cancer within 5 years exceptnon-melanoma skin cancers
Treatment with any investigational agents, within two months or 5 half-lives of theinvestigational product, whichever is longer.
Active illicit drug or more than moderate alcohol consumption.
Evidence of bacterial cholangitis within 6 months of enrollment
In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additionaltherapy at time of screening.
Chronic kidney injury (eGFR < 60)
Pregnancy or lactation
Uncontrolled hypertension with a systolic BP > 140 and a systolic BP > 90
Prohibited medications: current use of vitamin C and prednisone
Patients with a history or risk of cardiovascular conditions, including arrhythmia,long QT syndrome, congestive heart failure, stroke, or coronary artery disease
Patients with a history of kidney stones
Congenital or acquired immunodeficiencies
Other comorbidities including: diabetes mellitus, systemic lupus
An episode of acute cholangitis within 4 weeks of screening
Study Design
Connect with a study center
Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
United StatesActive - Recruiting
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