Phase IIb Study of GSK3228836 and Peginterferon in Hep B Subjects

• Research type

  Research Study

• Full title

  A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment with GSK3228836 followed by Pegylated Interferon Alpha 2a in Participants with Chronic Hepatitis B Virus (B-Together)

• IRAS ID

  288568

• Contact name

  Stephen Ryder

• Contact email

  Stephen.ryder@nuh.nhs.uk

• Sponsor organisation

  GlaxoSmithkline

• Eudract number

  2020-002979-35

• Duration of Study in the UK

  2 years, 6 months, 3 days

• Research summary

  Chronic Hepatitis B (CHB) is caused by the hepatitis B virus, which infects the liver and can cause liver damage that may lead to complications such as cirrhosis, liver failure, and liver cancer.

  Medicines are available, but patients frequently relapse after treatment is discontinued. GSK3228836 is an experimental medicine being developed for the treatment of CHB, Pegylated Interferon Alpha (PegIFN), is a drug currently used for the treatment of adult patients with CHB.

  This research study is being done to find out whether up to 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of Pegylated Interferon Alpha (PegIFN) can decrease the amount of viral substances in participants who are already receiving standard therapy, and whether this can be sustained once PegIFN treatment is discontinued.

  This study will enrol approximately 100 participants, with about 8 expected to be from UK. The total duration of the study, including screening, treatment, and post-treatment follow-up, is not expected to exceed 79 weeks for each participant.

  Participants will be allocated at random to either of the 2 treatment arms:
  Arm 1: 24 weeks GSK3228836 + 24 weeks PegIFN + 24 weeks off-treatment
  Arm 2: 12 weeks GSK3228836 + 24 weeks PegIFN + 36 weeks off-treatment

  Once participants are confirmed as suitable for the study, they will begin treatment and will continue their treatment with standard therapy throughout the study.

  During the treatment period with GSK3228836 a 300 mg loading/up front dose will be administered on Day 4 and Day 11 and will then attend weekly visits. After treatment they will be followed up for an additional 24 weeks.

  Tests and procedures will be conducted throughout the study and will include (but not limited to): blood tests, physical/symptom examinations, vital signs, pregnancy tests, electrocardiograms (heart tracings - ECGs) and questionnaire completion.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  20/EM/0284

• Date of REC Opinion

  22 Dec 2020

• REC opinion

  Further Information Favourable Opinion