Clinical Trials Logo
  1. Home
  2. Primary Biliary Cholangitis
  3. NCT05292872

Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients — HEROES PBC  

Primary Biliary Cholangitis Clinical Trial

Official title:
Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis

Clinical Trial Summary

This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria will be considered for this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05292872
Study type Observational
Source Intercept Pharmaceuticals
Contact
Status Completed
Phase
Start date March 28, 2022
Completion date July 15, 2022
View Details
See also
  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 NCT04076527 - Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Recruiting NCT05151809 - National Database 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