10 completed, 1 no longer available, 1 terminated. 6 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 5, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome Odevixibat, Placebo - Alagille Syndrome | Phase 3 | Completed | Albireo | 52 | 2021-03-19 | 2023-11-02 |
| A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH Elobixibat, Placebo oral tablet - NAFLD, NASH | Phase 2 | Completed | Albireo | 47 | 2019-06-06 | 2026-02-05 |
| Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions A4250 - Healthy Volunteers | Phase 1 | Completed | Albireo | 17 | 2018-07-05 | 2024-03-07 |
| This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2 A4250 (odevixibat), Placebo - PFIC1, PFIC2 | Phase 3 | Completed | Albireo | 62 | 2018-05-16 | 2025-11-28 |
| An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects 3 mg [14C]-A4250 capsule - Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis | Phase 1 | Completed | Albireo | 6 | 2017-01-31 | 2024-03-07 |
| A4250, an IBAT Inhibitor in Pediatric Cholestasis A4250 - Pediatric Cholestasis | Phase 2 | Completed | Albireo | 24 | 2015-08-01 | 2024-03-07 |
| IBAT Inhibitor A4250 for Cholestatic Pruritus A4250 - Biliary Cirrhosis, Primary | Phase 2 | Terminated | Sahlgrenska University Hospital | 9 | 2015-01-01 | 2017-02-23 |
| Double-blind, Randomised Study of A3384 in BAM/BAD A3384 - Bile Acid Malabsorption | Phase 2 | Completed | Albireo | 19 | 2014-03-01 | 2024-03-07 |
| A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 A4250, CRC (A3384), Questran - Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis | Phase 1 | Completed | Albireo | 94 | 2013-07-01 | 2024-03-07 |
| Study of A3309 in Patients With Dyslipidemia A3309, Placebo - Dyslipidemia | Phase 2 | Completed | Albireo | 36 | 2010-02-01 | 2024-03-07 |
| Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation A3309 - Constipation, Chronic Constipation | Phase 2 | Completed | Albireo | 190 | 2009-11-01 | 2017-03-22 |
| Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis Odevixibat - Progressive Familial Intrahepatic Cholestasis | No longer available | Albireo | 2026-07-23 |
Alagille Syndrome (3) · Cholestasis, progressive familial intrahepatic 1 (3) · Liver Cirrhosis, Biliary (3) · Cholestasis (2) · Constipation (1) · Dyslipidemias (1) · Non-alcoholic Fatty Liver Disease (1)
elobixibat (3) · odevixibat (3) · Cholestyramine Resin (1)
United States (6) · Sweden (5) · United Kingdom (5) · France (3) · Germany (3) · Belgium (2) · Canada (2) · Israel (2) · Italy (2) · Netherlands (2) · Poland (2) · Turkey (Türkiye) (2) · Australia (1) · Denmark (1) · Malaysia (1)
Hanns-Ulrich Marschall, MD (1) · Hans Graffner, MD (1)
PMID 21606974, PMID 26197999, PMID 35780807, PMID 36066745, PMID 38670135
2016 (1)