6 completed, 5 unknown, 2 active not recruiting, 1 recruiting. 15 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 6, Unknown 5, Active not recruiting 2, Recruiting 1, Terminated 1 |
| Phase 2 | 1 | Completed 1 |
Follow Primary Biliary Cirrhosis: new trials by email Literature Review of Primary Biliary Cirrhosis trials Research Report on Primary Biliary Cirrhosis
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 |
|---|---|---|---|---|---|---|
| Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) Obeticholic Acid Tablets, UDCA, Placebo - Primary Biliary Cirrhosis | Phase 3 | Unknown | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 120 | 2021-07-22 | 2021-07-26 |
| A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis Bezafibrate 200 MG Oral Tablet, Placebo, Ursodeoxycholic Acid - Primary Biliary Cirrhosis | Phase 3 | Unknown | Instituto Mexicano del Seguro Social | 11 | 2020-10-02 | 2021-02-12 |
| Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) Elafibranor 80mg, Placebo - Primary Biliary Cirrhosis | Phase 3 | Active not recruiting | Ipsen | 161 | 2020-09-24 | 2026-10-21 |
| Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule - Primary Biliary Cirrhosis | Phase 3 | Active not recruiting | Gilead Sciences | 340 | 2017-12-12 | 2026-05-04 |
| Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders Bezafibrate, Ursodeoxycholic Acid, Placebo (for Bezafibrate) - Primary Biliary Cirrhosis | Phase 3 | Unknown | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | 34 | 2016-10-01 | 2018-04-23 |
| Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis Fenofibrate, UDCA - Primary Biliary Cirrhosis | Phase 3 | Completed | Xijing Hospital of Digestive Diseases | 117 | 2016-04-08 | 2023-03-08 |
| Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid Fuzhenghuayu, UDCA - Primary Biliary Cirrhosis | Phase 3 | Unknown | Xijing Hospital of Digestive Diseases | 200 | 2016-01-01 | 2016-09-27 |
| Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis Fuzhenghuayu, UDCA - Primary Biliary Cirrhosis | Phase 3 | Unknown | Xijing Hospital of Digestive Diseases | 200 | 2016-01-01 | 2016-09-27 |
| Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid Fenofibrate, UDCA - Primary Biliary Cirrhosis | Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 104 | 2016-01-01 | 2026-10-30 |
| Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis Obeticholic Acid (OCA), Placebo - Primary Biliary Cirrhosis | Phase 3 | Completed | Intercept Pharmaceuticals | 217 | 2012-01-01 | 2021-05-06 |
| Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules - Primary Biliary Cirrhosis | Phase 3 | Completed | Beijing Friendship Hospital | 216 | 2009-09-01 | 2013-05-20 |
| Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) budesonide, budesonide placebo - Primary Biliary Cirrhosis | Phase 3 | Terminated | Dr. Falk Pharma GmbH | 62 | 2009-02-01 | 2020-01-28 |
| Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis Tetrathiomolybdate, Placebo - Primary Biliary Cirrhosis | Phase 3 | Completed | George Brewer | 29 | 2006-04-01 | 2017-05-23 |
| Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis Atorvastatin - Primary Biliary Cirrhosis, Hypercholesterolemia | Phase 3 | Completed | Medical University of Graz | 40 | 2006-01-01 | 2009-02-16 |
| Study of Combivir for Patients With Primary Biliary Cirrhosis Combination antiviral therapy, Placebo - Primary Biliary Cirrhosis | Phase 2 / Phase 3 | Completed | University of Alberta | 59 | 2004-01-01 | 2007-11-01 |
Liver Cirrhosis, Biliary (15) · Atherosclerosis (1) · Cholestasis (1) · Fibrosis (1) · Hypercholesterolemia (1)
Bile Duct Diseases (15) · Biliary Tract Diseases (15) · Cholestasis, Intrahepatic (15) · Digestive System Diseases (15) · Liver Cirrhosis (15) · Liver Diseases (15) · Pathologic Processes (15) · Pathological Conditions, Signs and Symptoms (15) · Cholestasis (14) · Fibrosis (14) · Arterial Occlusive Diseases (1) · Arteriosclerosis (1) · Cardiovascular Diseases (1) · Dyslipidemias (1) · Hyperlipidemias (1)
Ursodeoxycholic Acid (3) · Bezafibrate (2) · Fenofibrate (2) · obeticholic acid (2) · (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (1) · 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (1) · Atorvastatin (1) · Budesonide (1) · Tablets (1) · lamivudine, zidovudine drug combination (1) · seladelpar (1) · tetrathiomolybdate (1) · ursodoxicoltaurine (1)
Xijing Hospital of Digestive Diseases (4) · Beijing Friendship Hospital (1) · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (1) · Dr. Falk Pharma GmbH (1) · George Brewer (1) · Gilead Sciences (1) · Instituto Mexicano del Seguro Social (1) · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (1) · Intercept Pharmaceuticals (1) · Ipsen (1) · Medical University of Graz (1) · University of Alberta (1)
China (6) · United States (5) · Canada (4) · France (4) · Germany (4) · United Kingdom (4) · Austria (3) · Belgium (3) · Italy (3) · Mexico (3) · Spain (3) · Argentina (2) · Australia (2) · Chile (2) · Netherlands (2)
Andrew L Mason, MBBS MRCPI (1) · Bruce Bacon, MD (1) · Catherine Vincent, MD FRCPC (1) · Christian Weyer, MD (1) · Dong Ji Jia, Doctor (1) · Edgardo Eric Lopez Mendez, MD (1) · James Neuberger, MD FRCP (1) · Keith Lindor, MD (1) · Michael Trauner, M.D. (1) · Raoul Poupon, Professor (1)
PMID 25543678, PMID 10051462, PMID 10343514, PMID 10347106, PMID 12360466, PMID 15017671, PMID 15128074, PMID 15468571, PMID 16299032, PMID 16530513, PMID 16848809, PMID 16863557, PMID 17399846, PMID 18752324, PMID 19554543, PMID 19782361, PMID 22245904, PMID 22259000, PMID 22271046, PMID 22911624, PMID 23141888, PMID 24625898, PMID 24671010, PMID 27532829, PMID 2803071, PMID 30922873, PMID 31606455, PMID 32950590, PMID 33319187, PMID 36892506, PMID 37904314, PMID 37962077, PMID 40553148, PMID 41937506, PMID 42449190, PMID 42660235, PMID 9934730
2019 (1)