Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02937012
• Date of registration: 13/10/2016
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Public title: Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
• Scientific title: Efficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled Trial
• Date of first enrolment: October 2016
• Target sample size: 34
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02937012
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Mexico

Contacts

• Name: Edgardo Eric Lopez Mendez, MD

• Name: Edgardo Eric Lopez Mendez, MD

• Name: Edgardo Eric Lopez Mendez, MD
• Affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Key inclusion & exclusion criteria

Inclusion Criteria:

- Primary biliary cirrhosis diagnosis made by 2 of the 3 criteria:

1. Biochemical evidence of cholestasis with an alkaline phosphatase rise of 1.5
times the upper normal limit.

2. Anti-mitochondrial antibodies positivity

3. Histopathologic evidence of a nonsuppurative cholangitis and small bile ducts
destruction

- Use of ursodeoxycholic acid (UDCA) for at least 6 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:

1. Alkaline phosphatase more or equal to 1.5 times the normal upper limit

2. Aspartate transaminase more or equal to 1.5 times the normal upper limit

3. Bilirubin more than 1 mg/dL

- Signed informed consent.

Exclusion Criteria:

- No informed consent given to enrollment

- Actual or history of hepatic decompensation (ascitis, variceal upper gastrointestinal
bleeding, hepatic encephalopathy)

- Secondary immunosuppression caused by drugs (for example; steroids), use of statins or
fibrates in the last 6 months. The investigators will exclude patients with medical
indication of statin use.

- Coexistence of hepatopathy, chronic viral infections like C hepatitis virus, B virus
and HIV. Excessive alcohol intake, autoimmune hepatitis, non-alcoholic fatty liver
disease (diagnosed by histopathology), Wilson disease, hemochromatosis, celiac
disease, choledocolithiasis, non-controlled thyroid disease

- Post liver transplant

- Known allergy or intolerance to fibrates

- Pregnancy or women who desire to become pregnant

- Chronic kidney disease with a glomerular filtration less than 60 ml/min

- Patients under total anticoagulation with vitamin K antagonist



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: Bezafibrate

Drug: Placebo (for Bezafibrate)

Drug: Ursodeoxycholic Acid

Primary Outcome(s)

Complete biochemical response [Time Frame: 12 months]

Secondary Outcome(s)

Increase in liver transaminases or development of rhabdomyolysis [Time Frame: Follow-up every 3 months for 12 months.]

Secondary ID(s)

1757

Source(s) of Monetary Support

Please refer to primary and secondary sponsors