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A PHASE 3, Dose Response Study of Obeticolic acid (OCA) in Primary Biliary Cirrhosis INT-747-301A and  Long-term, Placebo-controlled Clinical Outcomes Study of Obeticholic Acid in Patients with PBC

Principal Investigator:   Henry Bodenheimer, Jr., MD
Time frame of study:   Closed to enrollment, subjects still active
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Duyang Kim at 212-844-6446 or dukim@chpnet.org


Summary:
This study is looking into how safe and effective Obeticholic acid (OCA) is in subjects Primary Biliary Cirrhosis. This will be determined by liver function and other biological measurements (blood tests). In the double-blind phase (meaning both the doctor and the subject do not know which treatment the subject is receiving), enrolled subjects will be randomized in a 1:1:1 ratio (33.3% chance) to 1 of 3 treatment arms: (a) placebo (sugar pill), (b) 10mg OCA, or (c) starting at 5mg of OCA and increasing to 10mg OCA. At 12 months, subjects will enter the long-term safety follow-up phase, in which all patients will start on 5mg OCA and may receive up to 25mg of OCA for up to 5 years. Subjects will be reimbursed for travel and all research procedures, including drug, are covered by the sponsor.


Eligibility Participants:

  • At least 18 years of age
  • Diagnosed with PBC

For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or dukim@chpnet.org