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

Phase 1

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

• Registration Number: EUCTR2006-006742-34-GB
• Lead Sponsor: Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-03
• Study Completion: 2013-03-08
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified