Phase 2 safety and antiviral efficacy study of inarigivir
Research type
Research Study
Full title
A PHASE 2, EXPLORATORY STUDY EVALUATING THE SAFETY AND ANTIVIRAL EFFICACY OF INARIGIVIR SOPROXIL IN NON-CIRRHOTIC, HEPATITIS B e ANTIGEN NEGATIVE SUBJECTS INFECTED WITH CHRONIC HEPATITIS B VIRUS AND RECEIVING OR STOPPING TREATMENT WITH A NUCLEOSIDE/NUCLEOTIDE INHIBITOR
IRAS ID
262481
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Spring Bank Pharmaceuticals, Inc.
Eudract number
2019-000896-17
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Chronic hepatitis B (CHB) is a major global health care challenge and one of the principal causes of chronic liver disease, cirrhosis and hepatocellular carcinoma (HCC). In 2015, an estimated 257 million people were living with CHB, and its worldwide incidence increases by 10 – 30 million annually due to the easily transmissible nature of the Hepatitis B Virus (HPB), despite global vaccination programs.
Current therapies include antiviral treatment with nucleosides/nucleotides (NUCs), and treatment with injectable interferon, which stimulates the immune system to attack the hepatitis B virus and regain control over it. However, these approaches fail to eliminate the infection in the vast majority of the patient population.
The purpose of this clinical study is to evaluate the safety and efficacy profile of inarigivir, a new antiviral treatment, in CHB patients in order to evaluate it as a potential treatment for CHB.
Cohort 1 of the study will include 20 HBeAg-negative (where the patients carry the HBV virus in a non-replicating status) CHB patients who will discontinue NUC treatment, and will only be administered inarigivir. Cohort 2 of the study will enrol 40 HBeAg-negative patients randomly assigned to two different arms, who will continue NUC therapy in addition to receiving inarigivir. Individual participation may be up to 3 years depending upon cohort and arm assignment. This includes a treatment period of up to 1 year and a post-treatment follow-up period of 2 years.
Throughout the study, participants will be required to complete certain procedures, such as blood tests, urine tests, electrocardiograms and an ultrasound. Participants will be recruited at study sites in the UK and Canada.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0628
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion