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Completed Phase 3 Interventional Results available

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

ClinicalTrials.gov ID: NCT04674761

Public ClinicalTrials.gov record NCT04674761. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 5:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

Study identification

NCT ID
NCT04674761
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Albireo
Industry
Enrollment
52 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 19, 2021 (Actual)
Primary completion
Sep 9, 2022 (Actual)
Completion
Sep 9, 2022 (Actual)
Last update posted
Nov 2, 2023

2021 – 2022

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of California - San Francisco San Francisco California 94158 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
Boston Children's Hospital Boston Massachusetts 02115 —
Children's Mercy Hospital and Clinics Kansas City Missouri 64108 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
The Childrens Hospital at Montefiore Albert Einstein School of Medicine The Bronx New York 10467 —
Oregon Health Science University School of Medicine Portland Oregon 97239 —
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04674761, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2023 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04674761 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →