RO7191863 in virologically supressed patients with chronic Hepatitis B
Research type
Research Study
Full title
An observer-blind, randomized study with an open-label part to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous administration of RO7191863 with multiple doses and different regimens in virologically suppressed patients with chronic hepatitis B infection
IRAS ID
257615
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
F.Hoffmann La-Roche Ltd
Eudract number
2018-003279-36
Duration of Study in the UK
2 years, 6 months, 24 days
Research summary
With currently available treatments, hepatitis B infection cannot be completely removed from the body in most chronically infected patients. Treatment can only stop the virus from making more virus copies and reduce damage to the liver, but it rarely cures the chronic infection completely. There is a need to develop new treatments for chronic hepatitis B that are more effective, well tolerated and safe.
This study will enrol patients who have chronic hepatitis B, are currently taking hepatitis B treatment with oral tablets (nucleoside/nucleotide analogues; NUCs), and have a good control of the virus based on their medical history.
Since cure is rare with current NUC treatment only, the study aims to see whether the study drug, RO7191863, may become part of a future treatment to cure hepatitis B from the liver. RO7191863 is an immune enhancer: it aims to improve the ability of the immune system to fight the hepatitis B virus.
The main part of the study aims to evaluate the safety, tolerability, pharmacokinetics (how the drug is absorbed and cleared from the body after administration), and pharmacodynamics (the effects of the drug on its target) of RO7191863 in five groups of participants who will receive different doses of RO7191863 (or placebo) at different intervals. RO7191863 will be given by injection under the skin (subcutaneously).
The duration of participation and number of visits will vary depending on which group the patient is enrolled into. Participants will undergo a number of procedures during the study, including: physical examination, vital signs measurement, assessment of the liver by transient elastography (similar to an ultrasound scan), blood and urine sample collection for laboratory tests, and ECGs.
Approximately 27 patients will participate in the main part of the study at approximately 15 research sites worldwide.
Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Finfectious-diseases%252Fchronic-hepatitis-b%252Fa-study-to-look-at-how-safe-different-doses-of-an-experimental-m.for-patient.html%2FNBTI%2F4uO_AQ%2FAQ%2F7a043ce7-3690-4271-b4b4-991346636810%2F1%2FjhgBKOWsyH&data=05%7C02%7Cwestminster.rec%40hra.nhs.uk%7Cebb985daf7a748ff482b08ddcaa3325a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638889524465621549%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=GSJZPt0vayzs6QeZlYrGG5mfh4CPGF750%2F680X%2FZqe8%3D&reserved=0
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0344
Date of REC Opinion
2 Apr 2019
REC opinion
Favourable Opinion