Efficacy of Different Doses of Bezafibrate in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC)
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 60 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
-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
Exclusion Criteria:
- Chronic Hepatitis B
- Chronic Hepatitis C
- Autoimmune Hepatitis
- Non-alcoholic fatty liver disease
- Primary sclerosing cholangitis
- Wilson Disease
- Alcohol related liver disease
- Primary biliary cirrhosis at cirrhotic stage
- Chronic kidney disease (Cr \>1.5 mg/dL or eGFR \<60 mL/min)
- Concomitant use of immunosuppressive drugs (Azatioprine, Mycophenolate, Tacrolimus, Cyclosporine, Corticoids)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
AMA positive PBC UDCA only
Not reported in this registry record.
Drug: UDCA 13-15 mg/kg/day
AMA positive PBC UDCA plus Bezafibrate 400mg
Not reported in this registry record.
Drug: UDCA 13-15 mg/kg/day + Bezafibrate 400 mg/day
AMA positive PBC UDCA plus Bezafibrate 800mg
Not reported in this registry record.
Drug: UDCA 13-15 mg/kg/day + Bezafibrate 800 mg/day
UDCA 13-15 mg/kg/day DRUG
UDCA 13-15 mg/kg/day (twice a day before meals)
UDCA 13-15 mg/kg/day + Bezafibrate 400 mg/day DRUG
UDCA 13-15 mg/kg/day (twice a day before meals) + Bezafibrate 400 mg/day (single dose before bedtime)
UDCA 13-15 mg/kg/day + Bezafibrate 800 mg/day DRUG
UDCA 13-15 mg/kg/day (twice a day before meals) + Bezafibrate 800 mg/day (two doses: morning and bedtime)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Normalization of alkaline phosphatase (ALP) levels
Time frame: 24 weeks
Evaluation of the proportion of patient who achieve normal values in the cholestatic marker ALP
Secondary measures
Biochemical Response Rate
Time frame: Week 24
Proportion of patients achieving normalization of biochemical markers including GGT, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin.
Deep response rate
Time frame: 24 weeks
Proportion of patients achieving normalization of biochemical markers ALP and Total Bilirubin below 0.6 mg/dL.
Change in Serum Alkaline Phosphatase (ALP) Levels
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Evaluation of the reduction in cholestatic marker ALP from baseline
Change in Pruritus Severity (Visual Analog Scale)
Time frame: 24 weeks
Pruritus assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10 cm, where 0 represents "no itching" and 10 represents "worst itching imaginable". Lower scores indicate a better outcome.
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline and every 4 weeks up to Week 24
Incidence of treatment-emergent adverse events, including muscle pain (myopathy) and renal function changes (Creatinine, Urea).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Sanatorio Integral IOTPosadas, Misiones Province, ArgentinaStatus unknown
Study team and timeline
- Lead sponsor
- Instituto de Biotecnologia de Misiones
- Study start
- Mar 1, 2023 Actual
- Primary completion
- Dec 1, 2025 Actual
- Study completion
- Dec 1, 2025 Actual
- First posted
- Nov 9, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Eficacia de Diferentes Dosis de Bezafibrato en combinación Con ácido ursodesoxicólico en Pacientes Con Colangitis Biliar Primaria
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026