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Completed Phase 3 Interventional Results available

This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

ClinicalTrials.gov ID: NCT03566238

Public ClinicalTrials.gov record NCT03566238. 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 Jul 22, 2026, 12:11 PM 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 Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

Study identification

NCT ID
NCT03566238
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Albireo
Industry
Enrollment
62 participants

Conditions and interventions

Conditions

Interventions

  • A4250 (odevixibat) Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
6 Months to 18 Years
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
May 15, 2018
Primary completion
Jul 26, 2020
Completion
Jul 27, 2020
Last update posted
Nov 27, 2025

2018 – 2020

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027
University of California, San Francisco San Francisco California 94143
Children's Hospital Colorado Denver Colorado 80045
Emory University School of Medicine Atlanta Georgia 30329
Johns Hopkins School of Medicine Baltimore Maryland 21287
Washington University School of Medicine St Louis Missouri 63110
Icahn School of Medicine at Mount Sinai New York New York 10029
Columbia University Medical Center - Presbyterian Hospital Building New York New York 10032
Cleveland Clinic Cleveland Ohio 44195
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
Baylor College of Medicine - Texas Children's Liver Center Houston Texas 77030

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 33 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03566238, 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 27, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03566238 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →