A Phase 4 interventional study of UDCA 13-15 mg/kg/day and UDCA 13-15 mg/kg/day + Bezafibrate 400 mg/day in Primary Biliary Cholangitis (PBC), sponsored by Instituto de Biotecnologia de Misiones. Completed at 1 site in Argentina. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Instituto de Biotecnologia de Misiones · Phase 4, Interventional, and Treatment
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.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →This is the only study on the registry with Instituto de Biotecnologia de Misiones as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-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 within 12 months
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: UDCA 13-15 mg/kg/day
Drug: UDCA 13-15 mg/kg/day + Bezafibrate 400 mg/day
Drug: UDCA 13-15 mg/kg/day + Bezafibrate 800 mg/day
UDCA 13-15 mg/kg/day (twice a day before meals)
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 (twice a day before meals) + Bezafibrate 800 mg/day (two doses: morning and bedtime)
Normalization of alkaline phosphatase (ALP) levels
Evaluation of the proportion of patient who achieve normal values in the cholestatic marker ALP
Time frame: 24 weeks
Biochemical Response Rate
Proportion of patients achieving normalization of biochemical markers including GGT, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin.
Time frame: Week 24
Deep response rate
Proportion of patients achieving normalization of biochemical markers ALP and Total Bilirubin below 0.6 mg/dL.
Time frame: 24 weeks
Change in Serum Alkaline Phosphatase (ALP) Levels
Evaluation of the reduction in cholestatic marker ALP from baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Change in Pruritus Severity (Visual Analog Scale)
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.
Time frame: 24 weeks
Incidence of Treatment-Emergent Adverse Events
Incidence of treatment-emergent adverse events, including muscle pain (myopathy) and renal function changes (Creatinine, Urea).
Time frame: Baseline and every 4 weeks up to Week 24
Plan to share: Yes — Researchers must submit a methodologically sound proposal with clear scientific aims. Data will be shared through a secure institutional repository after signing a data-sharing agreement ensuring patient confidentiality and compliance with local and international data protection laws. Study protocol and statistical analysis plan will also be available upon request.
Supporting information: Study protocol, Clinical study report
Time frame: Starting 12 months after completion of the study and for up to 3 years following publication
Access criteria: Researchers must submit a methodologically sound proposal with clear scientific aims
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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