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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: Enrolled

PEDFIC 2

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

Alagille Syndrome

Status: Ongoing OLE* Study

ASSERT

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

*The ASSERT open-label extension study is currently enrolled.

Biliary Atresia

Status: Ongoing OLE* Study

BOLD

Pivotal Phase 3, double-blind, randomized, placebo-controlled trial which enrolled 205 patients at 58 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.

*The BOLD open-label extension study is enrolling by invitation.

Additional Information

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

*Open-Label Extension