Clinical Trials

Albireo is currently working on several clinical trials. See below for details on the trials we have in progress.

Progressive Familial Intrahepatic Cholestasis (PFIC)

Status: Recruiting

PEDFIC 2

An open-label Phase 3 clinical trial evaluating the long-term safety and efficacy of odevixibat in children with PFIC.

Biliary Atresia

Status: Recruiting

BOLD

Pivotal Phase 3, double-blind, randomized, placebo-controlled trial which will enroll approximately 200 patients at up to 75 sites globally to evaluate the efficacy and safety of odevixibat in children with biliary atresia who have undergone a Kasai procedure before age three months. BOLD is the largest prospective intervention trial ever conducted in biliary atresia.

Alagille Syndrome

Status: Recruiting

ASSERT

Pivotal Phase 3 double-blind, randomized, placebo-controlled global Phase 3 trial of odevixibat in Alagille syndrome to evaluate the safety and efficacy of odevixibat in relieving pruritus in patients with Alagille syndrome.

Additional Information

For more information about the PEDFIC 2, ASSERT or BOLD studies, please visit ClinicalTrials.gov or contact medinfo@albireopharma.com.