Clinical Trials

REDUCe 2 (REpeated Drainage in Untreatable Cirrhosis) Study

REDUCe 2 study is a NIHR HTA funded multicentre trial following on from the earlier feasibility REDUCe Study(Macken L et al, APT 2020). The REDUCe 2 study is a randomised controlled trial comparing palliative long-term abdominal drains vs. large volume paracentesis in patients with refractory ascites due to cirrhosis. Recruitment commences Sept/Oct 2022 and will continue until June 2026. The study will be conducted across 35 sites in England and Scotland. If you are interested in participating please contact the Chief Investigator Sumita Verma (s.verma@bsms.ac.uk). The study abstract can be found by clicking on the link below.

Download REDUCe 2 abstract for BASL website PDF.pdf

Beta Blockers Or Placebo for Primary Prophylaxis of oesophageal varices (BOPPP)

This is a UK-wide multi-centre randomised controlled trial. It will address whether primary prophylaxis against future variceal haemorrhage with non-selective beta blockers is clinically and economically effective in patients with cirrhosis and small varices. The National Institute of Health Research Health Technology Assessment (NIHR: HTA) programme commissioned this research with funding secured of £2.3 million to consent, treat and follow up 1,200 patients at multiple hospitals across the UK. The trial is led by the Institute of Liver Sciences, Kings College Hospital and Kings College London Clinical Trials Unit. BOPPP will be one of the largest ever portal hypertension trials in this group of patients, and is currently (March 2020) being run at 24 UK-wide sites, with a further 25 sites being invited to open to recruitment over the next 6 months.

Please contact kch-tr.boppptrial@nhs.net for further information and for details of how your site can participate in BOPPP.

BOPPP Trial Manager: Joanne Leahy
Telephone: 020 3299 7142
Twitter: @boppptrial 

Further information is also available in this link:  Download BOPPP_Summary_Feb2020.pdf

ASEPTIC (Primary Antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis)

ASEPTIC is an NIHR HTA funded multi-centre trial to examine the efficacy of primary prophylaxis using the narrow spectrum antibiotic Co-Trimoxazole in patients with cirrhosis and ascites. 

We are still looking for sites and the study will run for the next 4 years. Please contact ctu.ASEPTIC@ucl.ac.uk for more details.

For more information:  Download ASEPTIC trial information for BSG and BASL.pdf.

Minimising Mortality from Alcoholic Hepatitis

The MRC Stratified Medicine application entitled ‘Minimising Mortality from Alcoholic Hepatitis’ will commence in April 2018 and will last for 5 years. The award was for £5M and will involve Imperial College (Mark Thursz, Harry Antonaides, Elaine Holmes), University of Birmingham (David Adams, Trish Lalor, Chris Weston), University College London (William Rosenberg), MRC Biostatistics Unit Cambridge (Paul Newcombe), University of Edinburgh (Stuart Forbes) and University of Plymouth (Ashwin Dhanda) as well as the 40 clinical sites recruiting patients.

Read more on the BSG website > here.

PRIMER-1 Study - Perioperative pembrolizumab and lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

This is a phase II randomised open-label study in Hepatocellular carcinoma (HCC). It is run by the CR UK & UCL Cancer Trials Centre and funded by Merck, Sharp & Dhome (MSD). PRIMER-1 will recruit patients from approximately 10 sites across the UK and the recruitment target is 60 patients over a period of 2 years.

The 3 groups are:

  • pembrolizumab before surgery
  • lenvatinib before surgery
  • pembrolizumab and lenvatinib before surgery

 After surgery everyone has pembrolizumab every 3 weeks for up to a year.

The aims of the trial are to find out:

  • how well these treatments work
  • whether these treatments reduce the chances of liver cancer coming back after surgery
  • what the side effects are and if they are manageable
  • whether the side effects might delay surgery

Please contact ctc.primer1@ucl.ac.uk for further information. 
PRIMER-1 Trial Manager: Michelle Hung.

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