Combination therapies for Chronic Hepatitis B
Research type
Research Study
Full title
A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL PLATFORM TRIAL TO EVALUATE EFFICACY AND SAFETY OF MULTIPLE COMBINATION THERAPIES IN PARTICIPANTS WITH CHRONIC HEPATITIS B
IRAS ID
269509
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2019-002086-35
Duration of Study in the UK
2 years, 6 months, 6 days
Research summary
Current available treatments for hepatitis B infection can stop the virus from multiplying and minimise liver damage. These treatments cannot completely cure the disease or remove it from the body. Therefore, these treatments may have to be given indefinitely. For this reason, it is important to develop new, safe and effective treatments for curing chronic hepatitis B infection, which patients will not need to receive for an indefinite duration.
This study will enrol patients who have chronic hepatitis B infection and are currently taking hepatitis B treatment with oral tablets (tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir) known as nucleoside/nucleotide analogues (NUCs).
The study aims to evaluate the effectiveness and to what extent the combination of new treatments with standard treatment is safe and tolerated in comparison to currently used standard therapy alone for treating chronic hepatitis B virus and to find out what effects the combination treatment has on patients. The study will also evaluate how these new combination treatments are processed by the body, and will investigate the antiviral and immune system effect of the combination treatments on the body.
The initial combination of new treatments combined with NUCs that will be tested in this study will use two investigational drugs called RO7020531 and RO7049389.
Each patient will take part in the study for approximately 2 years. The 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.
The study will be conducted at approximately 37 research sites worldwide.
REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0429
Date of REC Opinion
16 Apr 2020
REC opinion
Favourable Opinion