Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis

Summary

The German PBC Cohort is a multi-centric, observational (non-interventional) study with three parallel groups. The main objective of this observational study is to describe the course of Primary biliary cholangitis (PBC) in patients in Germany under routine treatment with approved drugs. Therefore, the effectiveness and safety/tolerability of PBC treatment options in a real-life setting will be evaluated.

Conditions

• PBC
• Primary Biliary Cholangitis

Interventions

DRUG

UDCA

Routine data is collected for UDCA therapy.

DRUG

Ocaliva

Routine data is collected for OCA therapy.

Sponsors & Collaborators

• RWTH Aachen University

  collaborator OTHER

• Zentrum für Klinische Studien Leipzig

  collaborator OTHER

• Intercept Pharma Europe Limited (IPEL)

  collaborator UNKNOWN

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• University Hospital Erlangen

  collaborator OTHER

• Medical care center for Gastroenterology, Berlin

  collaborator UNKNOWN

• Institute for Interdisciplinary Medicine, Hamburg

  collaborator UNKNOWN

• Leberhilfe Projekt gUG, Cologne

  collaborator UNKNOWN

• Hannover Medical School

  collaborator OTHER

• University of Leipzig

  lead OTHER

Principal Investigators

• Thomas Berg, Prof.Dr. · University of Leipzig

• Johannes Wiegand, Prof.Dr. · University of Leipzig

• Christian Trautwein, Prof.Dr. · RWTH Aachen University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-19

Primary Completion

2024-03-31

Completion

2024-03-31

Countries

• Germany

Study Locations