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NCT04336722 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

A Phase 3 study of Biliary Atresia, sponsored by Albireo, an Ipsen Company.

Active
Registry status
Phase 3
Development phase
254
Enrollment target
20
Study locations

NCT04336722 is a Phase 3 study of Biliary Atresia that is active but no longer recruiting, run by Albireo, an Ipsen Company. The registered enrollment target is 254 participants, below the 539-participant average among 7 other Biliary Atresia trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT04336722, a Phase 3 study of Biliary Atresia, is active but no longer recruiting, sponsored by Albireo, an Ipsen Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
254 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Biliary Atresia

Interventions

  • DRUG Placebo
  • DRUG Odevixibat

Study Locations (20)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Stanford Children's Health - Palo Alto
  • Rady Children's Hospital - San Diego
  • UCSF Benioff Children's Hospital San Francisco - San Francisco

New York

  • NYU Grossman school of Medicine - New York
  • Icahn School of Medicine at Mount Sinai - New York
  • NewYork-Presbyterian Morgan Stanley Children's Hospital - New York
  • The Children's Hospital at Montefiore - The Bronx

Missouri

  • Children's Mercy Hospital - Kansas City
  • Washington University in St. Louis - St Louis

Colorado

  • Children's Hospital Colorado - Aurora

Delaware

  • Nemours/Alfred I. duPont Hospital for Children - Wilmington

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • University of Miami - Miami

Georgia

  • Children's Healthcare of Atlanta - Emory University School of Medicine - Atlanta

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2020-07-08
Est. Completion 2026-06-26
Phase Phase 3

Sponsor

Albireo, an Ipsen Company

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04336722

The ClinicalTrials.gov registry entry for NCT04336722 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 539-participant average among 7 other Biliary Atresia trials with a reported enrollment target (53% lower). The listed sponsor is Albireo, an Ipsen Company, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Biliary Atresia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04336722 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Missouri.

Frequently Asked Questions

What is clinical trial NCT04336722 about?

NCT04336722 is a clinical study titled "Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)". 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.

What is the current status of trial NCT04336722?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2020-07-08. Estimated completion is 2026-06-26.

What conditions does trial NCT04336722 study?

This clinical trial studies the following conditions: Biliary Atresia.

What interventions are being tested in trial NCT04336722?

The interventions under investigation include: Placebo (DRUG), Odevixibat (DRUG).

Who is sponsoring clinical trial NCT04336722?

This trial is sponsored by Albireo, an Ipsen Company, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04336722 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.