Clinical trial
This Study Will Investigate the Efficacy and Safety of A4250 in Children With…
NCT03566238 · Albireo, Industry · Completed
Key facts
| NCT number | NCT03566238 |
|---|---|
| Title | This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2 |
| 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) |
| Acronym | PEDFIC 1 |
| Lead sponsor | Albireo, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | PFIC1, PFIC2 |
| Intervention type | Drug |
| Interventions | A4250 (odevixibat), Placebo |
| Enrollment | 62 |
| Start date | May 16, 2018 |
| Primary completion | Jul 27, 2020 |
| Completion | Jul 28, 2020 |
| First posted | Jun 25, 2018 |
| Last update posted | Nov 28, 2025 |
| Countries | Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Saudi Arabia, Spain, Sweden and 3 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: