EICHORCondition: Biliary Atresia · Sponsor: Albireo, an Ipsen Company
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * A male or female patient with a clinical diagnosis of BA * Age at Kasai HPE ≤90 days * Eligible to start study treatment within 3 weeks post-Kasai HPE Key Exclusion Criteria: * Patients with intractable ascites * Ileal resection surgery * ALT ≥10× upper limit of normal (ULN) at screening * Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization * Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis) * Choledochal cystic disease * INR \>1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized) * Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements * Weight \<3.5kg at randomization
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Children's Hospital Los Angeles | Los Angeles, California, United States | — |
| Stanford Children's Health | Palo Alto, California, United States | — |
| Rady Children's Hospital | San Diego, California, United States | — |
| UCSF Benioff Children's Hospital San Francisco | San Francisco, California, United States | — |
| Children's Hospital Colorado | Aurora, Colorado, United States | — |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington, Delaware, United States | — |
| Children's National Medical Center | Washington D.C., District of Columbia, United States | — |
| University of Miami | Miami, Florida, United States | — |
| Children's Healthcare of Atlanta - Emory University School of Medicine | Atlanta, Georgia, United States | — |
| Ann & Robert H. Lurie Children's Hospital | Chicago, Illinois, United States | — |
| Indiana University school of Medicine | Indianapolis, Indiana, United States | — |
| Johns Hopkins Children's Center | Baltimore, Maryland, United States | — |
+ 60 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04336722