6 completed, 3 unknown, 2 withdrawn. 11 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 6, Unknown 3, Withdrawn 2 |
| Phase 2 | 5 | Completed 2, Unknown 2, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Completed | Vinmec Research Institute of Stem Cell and Gene Technology | 20 | 2019-08-10 | 2024-06-06 |
| 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 |
| Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA Fenofibrate, UDCA - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Withdrawn | Beijing 302 Hospital | 2016-01-01 | 2021-09-17 | |
| Pilot Study of FFP104 Dose Escalation in PBC Subjects FFP104 - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Unknown | Fast Forward Pharmaceuticals | 24 | 2015-05-01 | 2016-08-24 |
| 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 |
| Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT 11C-CSar, ICG - Cholestasis, Primary Sclerosing Cholangitis | Phase 1 | Completed | University of Aarhus | 22 | 2013-06-01 | 2015-02-23 |
| Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis Biological: mesenchymal stem cell, ursodeoxycholic acid - Primary Biliary Cirrhosis | Phase 1 | Unknown | Robert Chunhua Zhao, MD, PhD | 20 | 2011-11-01 | 2012-08-03 |
| Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis conventional plus UC-MSC treatment, Conventional plus placebo treatment - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Unknown | Beijing 302 Hospital | 100 | 2011-10-01 | 2013-05-31 |
| Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC) Modafinil - Fatigue, Primary Biliary Cirrhosis | Phase 1 | Completed | Mayo Clinic | 40 | 2009-06-01 | 2012-01-18 |
| Initial Study of Rituximab to Treat Primary Biliary Cirrhosis rituximab - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Completed | University of California, Davis | 6 | 2007-01-01 | 2017-07-02 |
| Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis Non-myeloablative Hematopoietic Stem Cell Transplantation - Primary Biliary Cirrhosis | Phase 1 | Withdrawn | Richard Burt, MD | 2006-01-01 | 2012-10-08 |
Liver Cirrhosis, Biliary (11) · Alagille Syndrome (2) · Cholestasis, progressive familial intrahepatic 1 (2) · Biliary Atresia (1) · Cholangitis, Sclerosing (1) · Cholestasis (1) · Fatigue (1) · Inflammation (1) · Liver Cirrhosis (1)
Bile Duct Diseases (11) · Biliary Tract Diseases (11) · Cholestasis, Intrahepatic (11) · Digestive System Diseases (11) · Fibrosis (11) · Liver Diseases (11) · Pathologic Processes (11) · Pathological Conditions, Signs and Symptoms (11) · Cholestasis (10) · Liver Cirrhosis (10) · Congenital Abnormalities (3) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (3) · Abnormalities, Multiple (2) · Cardiovascular Abnormalities (2) · Cardiovascular Diseases (2)
Ursodeoxycholic Acid (2) · Cholestyramine Resin (1) · Congresses as Topic (1) · Fenofibrate (1) · Indocyanine Green (1) · Modafinil (1) · Rituximab (1) · Transplantation (1) · cholylsarcosine (1)
Albireo (2) · Beijing 302 Hospital (2) · Fast Forward Pharmaceuticals (1) · Mayo Clinic (1) · Richard Burt, MD (1) · Robert Chunhua Zhao, MD, PhD (1) · University of Aarhus (1) · University of California, Davis (1) · Vinmec Research Institute of Stem Cell and Gene Technology (1)
China (3) · United Kingdom (2) · United States (2) · Denmark (1) · Netherlands (1) · Vietnam (1)
Christopher L Bowlus, MD (1) · Fengchun Zhang, MD (1) · Fu-Sheng Wang, professor (1) · Keith D Lindor, M.D. (1) · Liem Nguyen (1) · M. Eric Gershwin, MD (1) · Richard Burt, MD (1) · Robert Chunhua Zhao, MD,PhD (1) · Susanne Keiding, M.D. D.Sc. (1) · Zhengsheng Zou, Dr. (1)
PMID 27148676, PMID 28249726, PMID 40907882
2014 (1), 2016 (1)