Status:
UNKNOWN
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Lead Sponsor:
Instituto Mexicano del Seguro Social
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased...
Eligibility Criteria
Inclusion
- PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]:
- History of elevated alkaline phosphatase levels.
- Anti-mitochondrial antibodies positivity
- Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
- Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
- Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
- Written informed consent.
- Age ≥ 18 years.
Exclusion
- Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
- Coexistence autoimmune hepatitis.
- Bilirrubin \>3mg/dl.
- For females, pregnancy or breast-feeding.
- Hepatocellular carcinoma.
- History or presence of spontaneous bacterial peritonitis.
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04751188
Start Date
October 2 2020
End Date
July 1 2021
Last Update
February 12 2021
Active Locations (1)
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1
Instituto Mexicano de Seguro Social
Puebla City, Mexico, 72000