CALIBRE – Carvedilol versus variceal band ligation in primary prevention of variceal bleeding in liver cirrhosis.
Trial Design
A multicentre randomised controlled, open-label, self-evident two-arm trial with internal pilot.
Aim
To investigate the clinical and cost-effectiveness of carvedilol versus variceal band ligation in patients with cirrhosis and medium to large oesophageal varices that have not bled.
Sample size
630 – CALIBRE is largest ever Phase III trial in cirrhosis.
Funding
NIHR HTA funded – £2.3m. Sponsor is University of Birmingham.
Recruitment
Over 4 years nationally. All acute NHS trusts and health boards in UK are potentially eligible
Primary endpoint
Any variceal bleeding within 1 year of randomisation. Full protocol has been published: https://bmjopengastro.bmj.com/content/6/1/e000290
Further information
[email protected]trials.bham.ac.uk . The CALIBRE website provides full details: https://www.birmingham.ac.uk/research/bctu/trials/portfolio-v/CALIBRE/CALIBRE.aspx