CALIBRE Trial

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