A prospective study into the utility of qHBsAg in management of CHB v1

• Research type

  Research Study

• Full title

  Optimising the management of chronic hepatitis B (CHB) in children and young people: A phase 2 prospective study to evaluate the use of quantitative hepatitis B surface antigen as a marker to risk stratify patients

• IRAS ID

  216039

• Contact name

  Patrick T F Kennedy

• Contact email

  p.kennedy@qmul.ac.uk

• Sponsor organisation

  Barts Health NHS Trust

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Chronic hepatitis B (CHB) affects >300 million people worldwide and can cause liver failure and liver cancer. In the UK, CHB is a disease of the major cities, reflecting recent migration patterns. The majority of those who develop CHB are infected with the virus at birth or in early childhood. Despite this, CHB is poorly understood and poorly managed in children and young people (CYP).
  CHB has many disease stages but safely identifying these stages/phases of the disease is difficult particularly in CYP; disease can be mild with virtually no progression; conversely disease may lead to the development of liver scarring which ultimately leads to liver failure or liver cancer. Currently used clinical tests are not accurate in defining disease phase and our recent work has demonstrated the limitations of these clinical stages / phases in CHB. This means current treatment and management decisions in CHB may be unsound. The aim of this work is to demonstrate that the addition of a simple blood test; quantitative hepatitis B surface antigen (qHBsAg); to currently used laboratory tests can more accurately define the disease and its various stages and predict in whom the disease will cause more harm. We will combine qHBsAg with other laboratory tests to identify patients with little or no disease where therapy is not needed, allowing us to reduce the number of hospital visits. Conversely, qHBsAg levels can also identify those at risk of more severe disease; so we plan to use this test in the real-life setting to improve patient care and the patient experience. We have considered the opinions of patients/parents when planning this research and their wish for safe but less frequent hospital visits. The combination of qHBsAg with the standard laboratory tests will improve patient management and at the same time reduce NHS costs.

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  18/LO/0333

• Date of REC Opinion

  30 Mar 2018

• REC opinion

  Further Information Favourable Opinion