NCT07926087CompletedPhase 4
Efficacy of Different Doses of Bezafibrate in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis
Eficacia de Diferentes Dosis de Bezafibrato en combinación Con ácido ursodesoxicólico en Pacientes Con Colangitis Biliar Primaria
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease that can progress to cirrhosis and hepatic failure. Ursodeoxycholic acid (UDCA) is the first-line treatment; however, up to 40% of patients exhibit an incomplete biochemical response. Bezafibrate (BZF), a pan-PPAR agonist, has shown promising results when combined with UDCA, improving biochemical parameters and symptoms such as pruritus. This prospective, randomized, open-label controlled study aims to evaluate the efficacy and safety of two doses of bezafibrate (400 mg/day vs 800 mg/day) combined with UDCA in patients with PBC over 24 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Nov 2025
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Instituto de Biotecnologia de Misiones
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07926087
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 1 Mar 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of immunosuppressive drugs (Azatioprine, Mycophenolate, Tacrolimus, Cyclosporine, Corticoids)
Other illness
- Chronic Hepatitis B
- Chronic Hepatitis C
- Autoimmune Hepatitis
- Non-alcoholic fatty liver disease
- Wilson Disease
- Alcohol related liver disease
Lab values
- Chronic kidney disease (Cr >1.5 mg/dL or eGFR <60 mL/min)
Other
- Primary sclerosing cholangitis
- Primary biliary cirrhosis at cirrhotic stage
Who the study is looking for
- -Adults (18-75 years) with a definitive diagnosis of PBC (EASL/AASLD criteria): Elevated ALP ≥6 months Positive AMA or specific anti-gp210/SP100 antibodies Compatible liver biopsy within 12 months
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanatorio Integral IOT | Posadas | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.