Primary Biliary Cirrhosis Clinical Trial
Official title:
A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04526665 -
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
|
Phase 3 | |
| Recruiting |
NCT02931513 -
sCD163 in PBC Patients - Assessment of Treatment Response
|
||
| Active, not recruiting |
NCT02924701 -
sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
|
||
| Completed |
NCT02659696 -
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
|
||
| Completed |
NCT02078882 -
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
|
Phase 4 | |
| Completed |
NCT01389973 -
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
|
Phase 2 | |
| Completed |
NCT01603199 -
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
|
N/A | |
| Completed |
NCT01857284 -
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
|
Phase 3 | |
| Completed |
NCT05374200 -
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)
|
N/A | |
| Recruiting |
NCT02937012 -
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
|
Phase 3 | |
| Completed |
NCT02376335 -
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis
|
Phase 2 | |
| Recruiting |
NCT01662973 -
Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04751188 -
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
|
Phase 3 | |
| Recruiting |
NCT04514965 -
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
|
||
| Recruiting |
NCT03668145 -
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis
|
N/A | |
| Completed |
NCT02955602 -
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
|
Phase 2 | |
| Completed |
NCT02557360 -
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
|
Phase 4 | |
| Recruiting |
NCT01440309 -
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
|
Phase 1 | |
| Completed |
NCT01249092 -
Pentoxifylline for Primary Biliary Cirrhosis
|
Phase 2 | |
| Completed |
NCT01510860 -
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
|
Phase 4 |