sCD163 in PBC Patients - Assessment of Treatment Response

NCT02931513 | Recruiting

• 1 other identifier: PBC AU 2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC. However, up to 40% of patients respond inadequate to this treatment. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR can predict response to treatment with UDCA in newly diagnosed patients with PBC.

Conditions

Primary Biliary Cirrhosis; Liver Inflammation; Ursodeoxycholic Acid

Outcome Measures

Primary Outcomes (1)

• UDCA response (ALP <3 times upper normal limit, AST <2 times upper normal limit, and bilirubin ≤1 mg/dL after one year of treatment)

  1 year

Secondary Outcomes (1)

• disease progression (blood samples, fibroscan, questionnaires)

  3 years

Study Arms (1)

PBC patients

Patients with primary biliary cholangitis

Other: Blood samples; Device: Fibroscan; Other: Questionnaires; Biological: Liver biopsy

Interventions

Blood samples OTHER

PBC patients

Fibroscan DEVICE

PBC patients

Questionnaires OTHER

PBC patients

Liver biopsy BIOLOGICAL

Liver biopsy will only be obtained if obtained as part of the diagnosis (will not be obtained for study purpose only)

PBC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with primary biliary cholangitis seen at Aarhus University Hospital, Aarhus, Denmark or at any regional hospital in the Central Region of Denmark

You may qualify if:

• Newly diagnosed with Primary biliary cholangitis
• No treatment with UDCA

You may not qualify if:

• Patient under 18 years
• Expected lifetime under 6 months
• Expected liver transplantation within 6 months
• Liver cancer
• Cirrhosis from other causes

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Aarhus C, Central Jutland, 8000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liverbiopsies if obtained during prognostication Blood samples for measuring sCD163 and sMR

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Hepatitis

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lars Bossen, PhD-student

CONTACT

+4522800676; larsbossen@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 13, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

DK (1)