A Phase 2a, Randomized, Blinded, Multicenter Study Investigating a Combination of AB-729 and VTP-300 to evaluate their safety and reactogenicity in Virologically-Suppressed Chronic Hepatitis B Participants.

Arbutus Biopharma0 个研究点目标入组 62 人开始时间: 2022年2月21日最近更新: 2024年9月2日

适应症

试验速览

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•1. Adult male or female participants, 18 to 65 years of age, inclusive.
•2. Male and female participants are eligible if they agree to use protocol-defined contraception
•3. Body mass index (BMI) greater than 18 kg/m2 and less than 35 kg/m2.
•4. Documented chronic HBV infection: positive HBsAg, HBV DNA, or HBeAg at least 6 months prior to the Screening Visit (historical documentation must be provided) and negative serum immunoglobulin M (IgM) anti-hepatitis B core-related antibody (HBcAb) at the Screening Visit
•5. Participants must have HBV DNA less than 20 IU/mL at screening and have been receiving either TAF, TDF, or ETV consistently for greater than 12 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit..
•6. HBsAg greater than 100 IU/ml and less than 5,000 IU/mL at Screening.
•7. All participants must have assessment of fibrosis demonstrating non-cirrhotic status.

•1. Known co-infection with HIV, hepatitis A, C, D, or E
•2. Any known preexisting medical or psychiatric condition that could interfere with the participant’s ability to provide informed consent or participate in study conduct, or that may confound study findings
•3. History of any clinically significant medical condition associated with chronic liver disease, evidence of decompensated liver disease, findings suggestive of hepatocellular carcinoma (HCC) at any time. or cirrhosis at any time
•4. Immunologically mediated disease or significant immunosuppression from disease or medication.
•5. Any known or suspected hypersensitivity, anaphylactic reactions or previous severe reactions to any of the constituents of AB-729 or VTP-300.
•6. ALT greater than 2 × ULN of the laboratory reference range.
•7. Direct or total bilirubin greater than 1.5 × ULN of the laboratory reference range.

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