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NCT03659916 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
A Phase 3 study, sponsored by Albireo, an Ipsen Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT03659916: Completed Phase 3 study, sponsored by Albireo, an Ipsen Company.
NCT03659916 is a Phase 3 study that has completed, run by Albireo, an Ipsen Company. The registered enrollment target is 116 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03659916, a Phase 3 study, has completed, sponsored by Albireo, an Ipsen Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study Summary
Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.
Primary Outcome
A positive pruritus assessment was defined as a scratching score of \<=1 or at least a 1-point drop from baseline on the Albireo ObsRO instrument. The percentage of positive pruritus assessment was calculated as the number of positive pruritus assessments divided by the total number of reported assessments recorded by each participant multiplied by 100.
Interventions
- DRUG A4250 (odevixibat)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-09-28 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 3 |
What the finished NCT03659916 record still lists
NCT03659916 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which A4250 (odevixibat) is the first listed.
NCT03659916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03659916 about?
NCT03659916 is a clinical study titled "Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC". Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.
What is the current status of trial NCT03659916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2018-09-28. Estimated completion is 2025-12-02.
What interventions are being tested in trial NCT03659916?
The interventions under investigation include: A4250 (odevixibat) (DRUG).
Who is sponsoring clinical trial NCT03659916?
This trial is sponsored by Albireo, an Ipsen Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03659916's enrollment target sits among peer trials
116 1643rd of 2000 higher than 357 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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