SOLSTICE
Research type
Research Study
Full title
A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants with Chronic Hepatitis D Virus Infection (SOLSTICE)
IRAS ID
1006064
Contact name
Daniel Cloutier
Contact email
Sponsor organisation
Vir Biotechnology, Inc.
Eudract number
2022-001993-78
Clinicaltrials.gov Identifier
Research summary
This is a phase 2 study to evaluate the efficacy, safety and tolerability of VIR-2218 + VIR-3434 in participants with chronic hepatitis D virus infection (HDV) (SOLSTICE). The sponsor conducting this study is Vir Biotechnology Inc. Hepatitis D virus is a virus that can infect the liver of humans who also have Hepatitis B virus (HBV) infection. Chronic HDV infection remains an important global public health problem affecting millions of persons. Chronic HDV infection significantly increases a person’s risk of developing liver cirrhosis and death. The HDV virus is dependent on the Hepatitis B virus, particularly the HBV surface antigen (sAg), to infect liver cells. So controlling HBsAg could lead to control of HDV and reduce the chances of developing severe liver disease in an already infected person. VIR-2218 is a synthetic small interfering ribonucleic (siRNA) therapeutic that has been shown to reduce HBsAg in persons with HBV infection. VIR-3434 is a monoclonal antibody that recognizes and binds HBsAg and prevents HBV virions from infecting liver cells. VIR-3434 has also been found to substantially reduce HBsAg in persons with HBV infection alone. The combination of VIR-2218 + VIR-3434 is anticipated to result in sustained reductions in HBsAg and may produce similar sustained control of HDV infection. For this study, male or female participants must be aged 18-70 and have a diagnosis of chronic HBV/HDV coinfection with any degree of hepatic impairment currently on NRTI (nucleoside reverse transcriptase inhibitor, a type of antiviral drug) therapy. A total of up to 58 patients will be enrolled and conducted at multiple clinical investigative sites globally. There are 4 cohort groups and participants will enrol sequentially based on a review of safety data. The total study duration is planned to be up to 102 weeks.
REC name
Wales REC 5
REC reference
22/WA/0231
Date of REC Opinion
8 Sep 2022
REC opinion
Further Information Favourable Opinion