Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

Korábbi kezelés

• History of cirrhosis as evidenced by prior Liver Elastography (Fibroscan) > 12 kilopascals (kPa), liver biopsy (F4 by METAVIR) or clinical evidence of decompensation (ascites, hepatic encephalopathy)
• Use of chronic immunosuppressive medications at a dose equivalent to 10 mg daily of prednisone or greater within past 6 months
• Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than non-melanoma skin cancer in previous 5 years, immunodeficiency syndrome
• Subject has received any investigational drug (including any investigational vaccines) within 90 days or 5 half-lives (whatever is longer) before screening for this study or is currently enrolled in an investigational study
• Prior liver or other solid organ transplantation

Más betegség

• History of or current hepatocellular carcinoma
• Hepatitis C Virus (HCV) RNA or anti-Hepatitis D Virus (HDV) positive
• HIV co-infection
• History of chronic liver disease other than HBV aside from fatty liver documented only on US
• Use of peginterferon therapy for HBV infection within past 12 months
• Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments, such as liver FNAs
• Patients on anticoagulation therapy or with any bleeding diathesis
• Patients with hemoglobinopathy (thalassemia, sickle cell disease etc)
• Other significant liver disease: alcoholic liver disease, autoimmune hepatitis, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson Disease or alpha-1 antitrypsin deficiency - as documented in clinical history

Laborértékek

• Alanine Aminotransferase (ALT) > 45 U/L
• Platelet count < 120,000,000,000/L
• The International Normalised Ratio (INR) > 1.3
• Bilirubin > 40 µmol/L
• Hemoglobin < 110 g/dL for women or 120 g/dL for men
• estimated Glomerular Filtration Rate (eGFR) < 45 cc/min

Egyéb

• Pregnancy or lactation
• Alpha Fetoprotein (AFP) > 50 ng/mL
• Unable to provide informed consent

• Age ≥ 18 to ≤65 years
• Chronic HBV infection with evidence of HBsAg-positivity x > 6 months
• Quantitative HBsAg 300 - 10,000 IU/mL
• On stable nucleos(t)ide therapy >1 year
• HBV DNA < 60 IU/mL on 2 occasions at least 12 weeks apart
• ALT ≤ 45 U/L on 2 occasions at least 12 weeks apart
• Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception 14 days before study drug administration through the study participation. Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through the study participation.
• Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through the study participation: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP. Male subjects must also agree to not donate sperm from the time of study drug administration through the study participation.
• Able and willing to sign informed consent