INTERCEPT- Phase lll trial for NASH patients

A phase 3, double-blind, randomized, placebo-controlled, multicenter trial will evaluate the safety and efficacy of Obeticholic acid (OCA) in patients with Non-Alcoholic Steatohepatitis (NASH).

There are currently no FDA-approved treatments for NASH. OCA is a modified bile acid that acts as a farnesoid X receptor agonist Activation of the farnesoid X receptor is thought to have hepato-protective, anti-inflammatory and anti-fibrotic effects. OCA is currently FDA-approved for the treatment of Primary Biliary Cholangitis (PBC).

Patients are eligible if they have liver biopsy evidence of stage 2 or stage 3 (bridging) fibrosis. They can also be included if they have stage 1 fibrosis accompanied by one or more of the following: obesity, diabetes or ALT >1.5 ULN. Patients who have evidence of other forms of chronic liver disease are excluded, as are patients who have had or are planning to have bariatric surgery. Patients with cirrhosis cannot participate.

Patients to be considered for the trial must have had a recent liver biopsy will be performed during screening. It is preferable to perform the initial liver biopsy as part of the screening process, as the appropriate number of unstained slides will be made available for pathologist review.

Eligible patients will be randomized to receive OCA 10mg, 25 mg or placebo in a 1:1:1 ratio. The study will assess whether OCA leads to an improvement in fibrosis at 18 months. Clinical liver-specific deterioration is an end-point that would lead to a patient’s termination from the study. The planned length of study duration is 6 years.

Principal Investigator: Hillel Tobias MD. PhD. Please contact our Clinical Trials team if you have a patient who may be eligible. Resmi Varughese Email: rvarughese@concordemed.com Office No. (212) 889-5544 x 152 Cell: (973) 666-8483

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