Primary Biliary Cholangitis Clinical Trial
Official title:
Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 24 months.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02516605 -
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
|
Phase 2 | |
Recruiting |
NCT06051617 -
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
|
Phase 3 | |
Recruiting |
NCT06060665 -
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
|
Phase 3 | |
Recruiting |
NCT05450887 -
Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis
|
Phase 3 | |
Recruiting |
NCT05050136 -
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
|
Phase 2 | |
Recruiting |
NCT05151809 -
National Database on Primary Biliary Cholangitis
|
||
Recruiting |
NCT04076527 -
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
|
||
Recruiting |
NCT04950764 -
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
|
Phase 1 | |
Completed |
NCT03545672 -
Early Identification of Myocardial Impairment in PBC
|
||
Completed |
NCT06098027 -
Study of [14C]CS0159 in China Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT04594694 -
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
|
Phase 2 | |
Completed |
NCT03602560 -
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
|
Phase 3 | |
Suspended |
NCT03684187 -
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
|
N/A | |
Recruiting |
NCT04617561 -
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
|
Phase 4 | |
Terminated |
NCT03092765 -
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
|
Phase 2 | |
Completed |
NCT04604652 -
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
|
Phase 2 | |
Not yet recruiting |
NCT06417398 -
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
|
Early Phase 1 | |
Recruiting |
NCT05919433 -
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
|
||
Completed |
NCT06309589 -
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
|
N/A | |
Withdrawn |
NCT05293938 -
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
|