Phase
Condition
Primary Biliary Cholangitis
Treatment
Osivelotor
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greaterthan 50 kg (greater than 110 lb)
Stable hepatic impairment that meets the criteria for Class A or B of the Child Pughclassification with no clinically significant change in disease status within the 28days prior to the screening visit
Stable concomitant medications for the management of individual participants'medical history
Exclusion
Exclusion Criteria:
Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection, prior status portacaval shunt surgery);
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellularprocess that is documented by medical history, physical examination, liver biopsy,hepatic ultrasound, computerized tomography scan, or MRI;
Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically activeStage 2 encephalopathy is allowed if, in the opinion of the investigator, theparticipant is able to provide informed consent.
Study Design
Connect with a study center
Orange County Research Center
Lake Forest, California 92630
United StatesSite Not Available
Elixia EPCT
Tampa, Florida 33618
United StatesActive - Recruiting
Genesis Clinical Research, LLC
Tampa, Florida 33603
United StatesSite Not Available
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
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