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