We work on behalf of patients and we partner with them. Through clinical trials for our investigational medicines, patients and their families play an integral role in helping us evaluate and obtain the evidence we need for regulatory approval in the U.S. and beyond.
Studies currently enrolling include:
Progressive Familial Intrahepatic Cholestasis: Phase 3 MARCH study
Evaluating the safety and efficacy of maralixibat in pediatric patients with progressive familial intrahepatic cholestasis.
Clinicaltrials.gov identifier: NCT03905330
Biliary Atresia: Phase 2b EMBARK study
Evaluating maralixibat in pediatric patients with biliary atresia post-Kasai procedure.
Clinicaltrials.gov identifier: NCT04524390
Cholestatic Liver Diseases: Phase 2 RISE study
Evaluating the safety and tolerability of maralixibat in infants 12 months or younger with PFIC and ALGS
Clinicaltrials.gov identifier: NCT04729751
Alagille syndrome: Expanded Access Program
The expanded access program is to provide access to maralixibat for eligible patients with cholestatic pruritus associated with Alagille syndrome.
For more information about the study including how to enroll, please visit the EAP website at algseap.com.
Clinicaltrials.gov identifier: NCT04530994
Primary Sclerosing Cholangitis: Phase 2b VISTAS study
Evaluating the safety and efficacy of volixibat in patients with pruritus (itch) caused by primary sclerosing cholangitis.
Clinicaltrials.gov identifier: NCT04663308
Intrahepatic Cholestasis of Pregnancy: Phase 2a/2b OHANA study
Evaluating volixibat in pregnant women with elevated serum bile acids associated with intrahepatic cholestasis of pregnancy.
Clinicaltrials.gov identifier: NCT04718961
For more information about how to enroll in our clinical trials, please contact us at firstname.lastname@example.org.