An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Albireo, an Ipsen Company
Study ID
NCT05426733
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Biliary Atresia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Odevixibat — DRUG
    Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).

Study Details

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

Key Dates

Start date
Jul 5, 2022
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Odevixibat (A4250)
    Capsules for oral administration once daily for 104 weeks.

Primary Outcome Measure

Proportion of patients who are alive and have not undergone liver transplant [ Time Frame: From baseline to Week 104 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
Children's Healhcare of Atlanta- Emory University school of medicineAtlantaGeorgia30322-
Indiana University school of MedicineIndianapolisIndiana46202-
Boston Children's HospitalBostonMassachusetts02115-
Children's Mercy Hospital and ClinicsKansas CityMissouri64108-
Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens HospitalNew YorkNew York10032-
Hassenfeld Children's Hospital at NYU LangoneNew YorkNew York10016-
The Childrens Hospital at Montefiore Albert Einstein School of MedicineThe BronxNew York10467-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COChildren's Healhcare of Atlanta- Emory University school of medicine· Atlanta, GAIndiana University school of Medicine· Indianapolis, INBoston Children's Hospital· Boston, MAChildren's Mercy Hospital and Clinics· Kansas City, MOColumbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital· New York, NY

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