Patients With Primary Biliary Cholangitis(PBC)

NCT07629128 | Active Not Recruiting

• 1 other identifier: 27454
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced stages, cirrhosis. Recent advances in the understanding of PBC pathophysiology have highlighted the central role of immune, inflammatory, and metabolic alterations in disease onset and progression.

Conditions

Primary Biliary Cholangitis; Liver Fibrosis; Cirrhosis, Liver; Blood Sugar; High

Keywords

Elafibranor; Seladelpar; peroxisome proliferator-activated receptor agonists(PPAR); Inflammatory markers

Outcome Measures

Primary Outcomes (3)

• Change from baseline to 3 months in glycated hemoglobin (HbA1c) levels (%)

  Assessment of change in glycated hemoglobin (HbA1c) levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.

  3-16 months

• Change from baseline to 3 months in fasting plasma glucose levels (mg/dL)

  Assessment of change in fasting plasma glucose levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.

  3-16 months

• Change from baseline to 3 months in continuous glucose monitoring-derived time in range (%)

  Assessment of change in percentage of time in glucose range (70-180 mg/dL) derived from continuous glucose monitoring between baseline and 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.

  3-16 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PBC patients initiating PPAR-agonist therapy in first or second line as part of routine clinical care.

You may qualify if:

• Age ≥ 18 years
• Confirmed diagnosis of PBC (biochemical criteria, antibody positivity and/or histological examination)
• The patient is a candidate for first- or second-line PPAR agonist therapy, as clinical practice, for the treatment of PBC
• The patient requires comprehensive metabolic monitoring, as per clinical practice
• Signed the informed consent form

You may not qualify if:

• Patients with a prior diagnosis of diabetes mellitus currently on insulin therapy
• Patients on treatment known to significantly affect glycemic values (e.g., GLP-1 receptor agonists, SGLT2 inhibitors, systemic corticosteroids)
• Patients with a life expectancy or estimated time to liver transplantation of less than 6 months

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Liver Cirrhosis; Hyperglycemia

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Francesca Romana Ponziani

  Fondazione Policlinico Universitario Agostino Gemelli,IRCCS,Roma

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 5, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Locations

IT (1)