Overview of the Research
Liver disease is the fifth most common cause of mortality and morbidity in the United Kingdom. The Hepatology Research Team at Bradford Royal Infirmary (BRI) directly contributes to Department of Health (DoH) Clinical Research Network sponsored research, developing evidence that helps towards the care of patients with chronic liver diseases within the Yorkshire and Humber region. We also work closely with industry to run early and late phase studies in Hepatology.
We have also implemented new technology within the Hepatology unit. The Fibroscan machine is a non-invasive method to assess liver stiffness (correlated to fibrosis), which can be used to assist diagnosis and disease evaluation, in conjunction with existing methods. This technology aims to improve patient care and attract cutting edge Hepatology research to the BRI.
We are also active members of the Yorkshire and Humber Liver Network
Led by Dr Sulleman Moreea, Consultant Hepatologist and Gastroenterologist, in the past two years we have developed a dedicated research team as part of the Digestive Diseases Centre (DDC) at the BRI.
The team currently consists of two consultants, one full and one part time Specialist Research Nurses and one administrative support assistant.
We aim to ensure that high quality research can be offered to all who wish to be involved and delivered by staff who are compassionate and knowledgeable. As a research team, we are committed to developing a diverse research portfolio in Hepatology.
A phase I, randomised, double-blind, placebo-controlled, multi-centre, ascending-dose trial to evaluate the safety, tolerability and immunogenicity of Vaccine FP-02.2 in HBeAg-negative hepatitis B patients as an add-on treatment to entecavir or tenofovir
HCV Research UK – Host and viral factors associated with outcomes of infection with hepatitis C virus-aims to investigate the role of a number of host and viral factors in determining outcome of infection with hepatitis C virus. The relative contributions of a number of biological and genetic factors towards disease outcome will be analysed, including age at infection, gender, IL-28B genotype, and duration of infection, obesity (body mass index), alcohol consumption, ethnicity, and stage of liver disease, co-infection with HIV or HBV, and viral genotype.
Research study into the genetic causes of Primary Biliary Cirrhosis (PBC)- To identify genetic factors which lead to the development of PBC. Study design: case-control genetic association study.
MTX: Evaluation of the role of AST: ALT ratio, ELF markers and Fibroscan in the detection of methotrexate induced hepatotoxicity-Methotrexate is an effective treatment for psoriasis and is now recommended by the National Institute of Clinical Excellence (NICE) as the first line systemic therapy for adult patients’ with moderate to severe psoriasis. Similarly methotrexate is a common disease modifying agent used in rheumatoid arthritis.
Methotrexate use is limited by organ toxicity, including hepatotoxicity which leads to liver failure and transplantation. Liver damage secondary to methotrexate is an important concern for clinicians prescribing the drug.
Patients on methotrexate require regular monitoring of serum liver enzymes, however is known that liver enzymes do not reflect the degree nor the progression of liver disease. Liver biopsy is still considered the standard test, and although not strictly followed recommendations from guidelines encourage regular biopsies. This procedure is unpleasant associated with significant pain and other complications. There are also limitations in the histological evaluation of liver biopsy.
This has led to the development of non-invasive tests. Currently the most widely used is the serial measurement of amino-terminal propeptide of type iii collagen (PIIINP) through blood tests. Studies suggest that serial PIIINP assays are sensitive but not specific in detecting liver disease. Therefore there is the need to assess and introduce other non-invasive monitoring tests. ELF markers (hyaluronic acid, Amino-terminal propeptide-of-type-iii-collagen, tissue- inhibitor of matrix-metaloproeteinase-1) and Fibroscan (transient elastography) have been validated in the detection of liver fibrosis.
This study will investigate the best way to detect methotrexate associated liver disease in patients with psoriasis and rheumatoid arthritis, looking at the role AST:ALT ratio, ELF markers and Fibroscan. This research will inform an optimal pathway for monitoring of liver disease in these patients, thereby reducing the number of liver biopsies routinely performed.
NASH A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
AbbVie-A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of
Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C
Virus (HCV) Genotypes 1-6 Infection and Aspartate aminotransferase to Platelet Ratio
Index (APRI) ≤ 1
Number of “Global 1st patient” achievements
Number of “Top Recruiter” achievements
Number of studies “delivered to time and target”
Other achievements, eg, radio/TV appearnces/newspaper articles
STOPAH: Steroids or Pentoxifylline for Alchoholic Hepatitis
DILIGEN: A study on the genetics of drug-related liver disease
ELUCIDATE: ELF to Uncover Cirrhosis as an Indication for Diagnosis and Action for Treatable Events
PIANO: Phase 2 Primary Biliary Cirrhosis (PBC) study
Study To Evaluate Pegasys SVR in Genotype 3 HCV infected patients
HEP FREE: Chronic Viral Hepatitis in First and Second Generation Immigrants from ‘At Risk’ Countries
Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding (HALT)