This is the clinical trial work stream. The main focus of workstream 3 is to evaluate the impact of three new biomarkers for liver damage - together called the ‘Enhanced Liver Fibrosis’ or ELF test.
Workstream 3 performs a multicentre randomised clinical trial called ELUCIDATE. The aim of this trial is to determine whether ELF can give early warning of dangerous liver damage (cirrhosis) and therefore reduce the risk of major complications. This trial has the potential to radically alter the way in which patients with liver disease can be looked after.
The flow diagram below outlines the patient pathway through the trial.
*Registration line due to close 28/02/2013
**Randomisation line due to close 30/04/2013Recruitment
Recruitment for ELUCIDATE was slightly delayed in the initial few months due to unexpected delays in trial set up. However, recruitment progressively increased with February 2013 being a record month for registrations. Following closure of recruitment in April 2013, we can report that a total of 37 sites were open, leading to 878 patients randomised - only 122 short of the planned 1000, which will provide a satisfactory 85% power for the primary outcome analysis. The graph below illustrates the final accrual figures for the ELUCIDATE trial.
Following closure of registration and randomisation, the next steps for workstream 3 are as follows:
We will report on the following by January 2015: