Trial Summary
What is the purpose of this trial?This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.
The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body.
This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.
What safety data is available for VIR-3434 in treating Hepatitis B?The provided research does not contain specific safety data for VIR-3434. It focuses on general safety data for various hepatitis B vaccines, including adverse events reported in the Vaccine Adverse Event Reporting System (VAERS) and a study on an experimental hepatitis B vaccine with AS04 adjuvant. None of these studies mention VIR-3434 directly.124513
Is the drug VIR-3434 a promising treatment for Hepatitis B?The information provided does not mention VIR-3434 or its effectiveness for Hepatitis B, so we cannot determine if it is a promising treatment based on this data.36789
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop taking your current medications. However, you must be on stable nucleos(t)ide therapy for more than a year to participate.
What data supports the idea that VIR-3434 for Hepatitis B is an effective drug?The available research does not provide specific data on the effectiveness of VIR-3434 for Hepatitis B. Instead, it discusses other treatments like adefovir, lamivudine, clevudine, entecavir, and tenofovir. For example, adefovir showed a virological response in 40.5% of patients, and clevudine was compared with entecavir in antiviral-naive patients. Without specific data on VIR-3434, we cannot conclude its effectiveness compared to these treatments.910111214
Eligibility Criteria
This trial is for individuals with chronic hepatitis B. Participants will be involved in the study for about 104 weeks, receiving VIR-3434 weekly for the first 48 weeks and then being followed up for another 48 weeks.Inclusion Criteria
I am between 18 and 60 years old.
I am not pregnant or I am postmenopausal.
I agree not to donate eggs or undergo IVF during the study.
I am a male and will use effective birth control during the study.
I agree not to donate sperm during the study.
I have been on stable antiviral therapy for over a year.
Exclusion Criteria
I have a history of severe liver disease.
I have or had liver cancer.
I am co-infected with HIV.
I have a chronic liver condition, but it's not hepatitis B or just fatty liver.
I have been on strong immune system suppressing drugs recently.
I don't have major health issues that could affect this study.
I have had a liver or other solid organ transplant.
I have a significant liver condition such as alcoholic liver disease or autoimmune hepatitis.
I am unable to understand and agree to the study's procedures and risks.
I have a blood disorder like thalassemia or sickle cell disease.
I have not taken any experimental drugs or vaccines within the last 90 days or longer, depending on the drug.
I am on blood thinners or have a bleeding disorder.
Treatment Details
The trial is testing VIR-3434, an experimental drug aimed at targeting and clearing the HBsAg of hepatitis B virus from the body. It's a Phase II study where all participants receive the actual medication without any placebo.
1Treatment groups
Experimental Treatment
Group I: VIR-3434Experimental Treatment1 Intervention
VIR-3434 300 mg subcutaneous injection every 4 weeks\*48 weeks
Find a clinic near you
Research locations nearbySelect from list below to view details:
University Health NetworkToronto, Canada
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
References
Comparative safety of two recombinant hepatitis B vaccines in children: data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD). [2019]Preliminary review of data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1994, revealed that more serious adverse events were reported in children who received a specific brand of recombinant hepatitis B (HepB) vaccine.
Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998. [2019]To evaluate reports of neonatal deaths (aged 0-28 days) after hepatitis B (HepB) immunization reported to the national Vaccine Adverse Event Reporting System (VAERS).
Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study. [2019]Lamivudine-resistant hepatitis B virus (HBV) is found in about 15-32% of infected patients with or without co-infection with HIV-1 after 1 year of lamivudine therapy. Adefovir dipivoxil is active in vivo and in vitro against wild-type and lamivudine-resistant HBV. We assessed the safety and efficacy of a once daily dose of adefovir dipivoxil in an open-label trial for the treatment of lamivudine-resistant HBV infection in HIV-1-infected patients.
Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. [2006]The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers >or=15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.
A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: analysis of the Vaccine Adverse Event Reporting System (VAERS) database and literature review. [2022]Adverse events and positive re-challenge of symptoms reported in the scientific literature and to the Vaccine Adverse Event Reporting System (VAERS) following hepatitis B vaccination (HBV) were examined.
[Relationship between B virus hepatitis genotypes and therapeutic efficacy in early treatment for chronic hepatitis B by using lamivudine]. [2013]To investigate the relationship between hepatitis B virus (HBV) genotype and therapeutic efficacy during the early phase of lamivudine treatment.
A case-control study of response to lamivudine therapy for 2 years in Japanese and Chinese patients chronically infected with hepatitis B virus of genotypes Bj, Ba and C. [2020]In eastern Asian countries, hepatitis B virus (HBV) genotype Ba (HBV/Ba), HBV/Bj and HBV/C are prevalent. The aim was to investigate the response or resistance to lamivudine therapy among patients with different HBV genotypes.
Comparison of hepatitis B virus subgenotypes in patients with acute and chronic hepatitis B and absence of lamivudine-resistant strains in acute hepatitis B in Japan. [2013]Hepatitis B virus (HBV) has been classified into eight genotypes and can be further divided into several subgenotypes that have different geographic distributions. Because of increased human migration, the prevalence of rare subgenotypes is increasing in Japanese patients with acute hepatitis B. Lamivudine-resistant strains of HBV have begun to emerge in association with chronic hepatitis B. The aim of this study was to investigate the distribution of HBV subgenotypes and lamivudine-resistant strains in patients in Japan with acute hepatitis B. One hundred twenty-three patients with acute hepatitis B and 123 with chronic hepatitis B were studied. HBV subgenotypes and lamivudine-resistance mutations were determined by direct sequencing of the preS and polymerase region, respectively. HBV subgenotypes Aa (n=3), Ae (n=23), Ba (n=7), Bj (n=3), Cs (n=7), Ce (n=76), D (n=2), and H (n=2) were detected in patients with acute hepatitis. In patients with chronic hepatitis, HBV subgenotypes Ae (n=4), Ba (n=1), Bj (n=18), and Ce (n=100) were found. Non-common Japanese subgenotypes, that is, non-Bj and non-Ce, were detected more frequently in patients with acute hepatitis (35.8%) than in patients with chronic hepatitis (4.1%) (Odds ratio, 0.076; 95%CI, 0.029-0.200; P
Evaluation of initial virological response to adefovir and development of adefovir-resistant mutations in patients with chronic hepatitis B. [2013]The aims of the present study were to assess initial virological response (IVR) to adefovir (ADV) treatment for chronic hepatitis B, to identify patients with suboptimal response and to determine the incidence of ADV-resistant mutants. All patients treated with ADV for at least 12 months were evaluated for virological response and ADV resistance. IVR was defined as a reduction > or = 4 log10 IU/mL in hepatitis B virus (HBV)-DNA at month 6. Forty-two patients were analysed. Mean treatment duration was 23 +/- 7 months; 50% had prior lamivudine (LAM) therapy (LAM resistance 62%); 88% were hepatitis B e antigen (HBeAg)-negative; and 76% carried genotype D. IVR was seen in 40.5% of patients. Higher baseline ALT level was the only factor associated with IVR (P = 0.043). Patients with IVR achieved undetectable HBV-DNA at month 12 in 77% of cases compared with only 5% of those without IVR (P or = 4 log10 IU/mL in HBV-DNA at month 6 is a useful tool to predict virological response at month 12 and to identify patients with suboptimal response to ADV. Cumulative probability of ADV resistance is higher than previously reported for nucleos(t)ide-naïve patients.
Lamivudine-resistant chronic hepatitis B: an observational study on adefovir in monotherapy or in combination with lamivudine. [2016]In lamivudine-resistant patients with chronic hepatitis B (CHB), we compared efficacy, predictive response factors and changes in viral mutants in two antiviral approaches with adefovir.
Virologic response at 12 months of treatment predicts sustained antiviral efficacy in patients with adefovir-treated Lamivudine-resistant chronic hepatitis B. [2021]The aim of our study was to define the potential role of virologic response at 12 months of treatment (VR12) in predicting subsequent virologic and clinical outcomes in adefovir (ADV)-treated lamivudine-resistant chronic hepatitis B.
Long-term treatment outcomes of clevudine in antiviral-naive patients with chronic hepatitis B. [2021]To evaluate the treatment outcomes of clevudine compared with entecavir in antiviral-naive patients with chronic hepatitis B (CHB).
Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women. [2023]To characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.
Comparison of patients using lamivudine, entecavir, and tenofovir according to liver fibrosis markers fibrosis-4 and aspartate aminotransferase-to-platelet ratio index scores. [2023]It was intended to assess the efficacy of lamivudine, entecavir, and tenofovir regimens in the management of chronic hepatitis B (CHB) guided by Fibrosis-4 (FIB-4) and aspartate aminotransferase-to-platelet ratio index (APRI) scores.