The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006742-34-GB

Enrollment

Registered

2007-06-03

Start date

2007-12-20

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary biliary cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis

Interventions

Trade Name: Ezetrol Product Name: Ezetimibe Product Code: EZT Pharmaceutical Form: Tablet INN or Proposed INN: EZETIMIBE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients with diagnosis of PBC. 2. Aged over 19yo. 3. Male and Female. 4. Able to give consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with other causes of liver disease. 2. Patients who are recruited and taking part in another reseach study. 3. Patients who are unable to give informed consent. a. Adults with learning disabilities b. Children under 16 c. Females who are pregnant or lactating. d. Adults who are unconscious or very severely ill e. Adults who have a terminal illness f. Patients with a diagnosis of cancer. g. Adults in emergency situations h. Adults with serious mental illness i. Adults with dementia j. Prisoners 4. Patients on statin, fibrate, ciclosporin 5. Patients with rare hereditary problems of galactose intolerance

Design outcomes

Primary

Measure	Time frame
Main Objective: The effect of ezetimibe on cholesterol levels. Previous studies have shown that ezetimibe 10mg reduces cholesterol levels by 18%. ; Secondary Objective: To establish the effects, toxicity and therefore safety of ezetimibe in patients with primary biliary cirrhosis by monitoring liver function enzymes. Ezetimibe has been found to produce non-significant changes in liver enzymes. The effect of pyridoxine on haemoglobin concentration. Because previous pyridoxine should increase haemoglobin only in patients who have a deficiency, we would expect only occasional, individual changes. The effect on the group mean haemoglobin is likely to be small (<0.5 g/100ml). ; Primary end point(s): In the general population, previous drug trials showed ezetimibe produces a decrease in plasma total choleserol concentration of ~18%. Reductions of even 5% are thought to be clinically useful and can be acheived by lifestyle intervention. Our primary end-point is the reduction in plasma total cholesterol concentration achieved by ezetimibe in patients with PBC.	—

Measure

Time frame

Main Objective: The effect of ezetimibe on cholesterol levels. Previous studies have shown that ezetimibe 10mg reduces cholesterol levels by 18%. ; Secondary Objective: To establish the effects, toxicity and therefore safety of ezetimibe in patients with primary biliary cirrhosis by monitoring liver function enzymes. Ezetimibe has been found to produce non-significant changes in liver enzymes. The effect of pyridoxine on haemoglobin concentration. Because previous pyridoxine should increase haemoglobin only in patients who have a deficiency, we would expect only occasional, individual changes. The effect on the group mean haemoglobin is likely to be small (<0.5 g/100ml). ; Primary end point(s): In the general population, previous drug trials showed ezetimibe produces a decrease in plasma total choleserol concentration of ~18%. Reductions of even 5% are thought to be clinically useful and can be acheived by lifestyle intervention. Our primary end-point is the reduction in plasma total cholesterol concentration achieved by ezetimibe in patients with PBC.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026