Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The study will enroll patients with Primary Biliary Cholangitis (PBC) for whom treatment with PPAR agonists has been prescribed in routine clinical practice, either as first-line or second-line therapy according to current clinical indications.
The study procedures include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
PBC patients initiating PPAR-agonist therapy in first or second line as part of routine clinical care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesca Romana Ponziani | Fondazione Policlinico Universitario Agostino Gemelli,IRCCS,Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli | Roma | 00168 | Italy |
Not provided
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D008103 | Liver Cirrhosis |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |