# Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

> **NCT03659916** · PHASE3 · COMPLETED · sponsor: **Albireo, an Ipsen Company** · enrollment: 116 (actual)

## Conditions studied

- Progressive Familial Intrahepatic Cholestasis

## Interventions

- **DRUG:** A4250 (odevixibat)

## Key facts

- **NCT ID:** NCT03659916
- **Lead sponsor:** Albireo, an Ipsen Company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-09-28
- **Primary completion:** 2024-02-15
- **Final completion:** 2025-12-02
- **Target enrollment:** 116 (ACTUAL)
- **Last updated:** 2026-04-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03659916

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03659916, "Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT03659916. Licensed CC0.

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