Treatment uptake of second line therapies in patients with primary biliary cholangitis and missing deep response on ursodeoxycholic acid

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036066

Enrollment

600

Registered

2025-09-23

Start date

2025-05-02

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

K74.3

Interventions

Group 1: Retrospective data analysis without intervention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) PBC has been diagnosed according to EASL criteria 2) Age > 18 years 3) UDCA therapy for at least 12 months

Exclusion criteria

Exclusion criteria: 1) No specific exclusion criteria

Design outcomes

Primary

Measure	Time frame
Proportion of patients with ALP 1.1 – 1.5 x ULN in combination with liver stiffness measurement = 10 kPa and age = 62 years who are on UDCA monotherapy and do not receive a second-line therapy yet	—

Secondary

Measure	Time frame
1. Proportion of patients with ALP 1.1 – 1.5 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet 2. Proportion of patients with ALP > 1.5 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet (“Paris II criteria”) 3. Proportion of patients with ALP > 1.67 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet (“POISE criteria”) 4. Proportion of patients with cirrhosis who are on UDCA monotherapy and do not receive a second-line therapy 5. Rationale or reasons for treating physicians not to prescribe second line therapies although formally indicated	—

Measure

Time frame

1. Proportion of patients with ALP 1.1 – 1.5 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet 2. Proportion of patients with ALP > 1.5 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet (“Paris II criteria”) 3. Proportion of patients with ALP > 1.67 x ULN who are on UDCA monotherapy and do not receive a second-line therapy yet (“POISE criteria”) 4. Proportion of patients with cirrhosis who are on UDCA monotherapy and do not receive a second-line therapy 5. Rationale or reasons for treating physicians not to prescribe second line therapies although formally indicated

—

Countries

Germany

Contacts

Public ContactJohannes Wiegand

Universitätsklinikum Leipzig, Medizinische Klinik II, Bereich Hepatologie

johannes.wiegand@medizin.uni-leipzig.de+493419712330

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026