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PRO_DPCS

Patient Reported Outcomes in a Real-World Setting of Primary Biliary Cholangitis - Nation-Wide Prospective Observational Cohort Study – - PROs in Dutch PBC Cohort Study (PRO-DPCS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58096
Enrollment
565
Registered
2025-02-21
Start date
2026-06-11
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Interventions

No investigational product or intervention will be investigated. Digital questionnaires will be sent out to participants.&nbsp

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:-              = 18 years of age-              Diagnosis of PBC according to the international guidelines

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:-              Inability to give informed consent

Design outcomes

Primary

MeasureTime frame
Primary parameters: various PROMs related to HRQoL, pruritus and fatigue.

Secondary

MeasureTime frame
Secondary parameters: •         Liver-related biochemistry (also incorporated in various risk models)•         Development of cirrhosis with or without signs of portal hypertension•         Liver-related complications (ascites, spontaneous bacterial peritonitis, jaundice, variceal bleeding, hepatic encephalopathy, liver failure, hepatocellular carcinoma, liver transplantation and death)•         Liver-related hospitalization •         Use of (liver-related) medication•         vascular events (cerebrovascular events, cardiovascular events or end-stage renal failure)

Countries

Netherlands

Contacts

Public ContactA.J.P van der Meer

Erasmus MC, Universitair Medisch Centrum Rotterdam

pbc@erasmusmc.nl010 703 59 42

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026