Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
Chronic Hepatitis b
About this trial
This is an interventional treatment trial for Chronic Hepatitis b focused on measuring Hepatitis B virus, Chronic hepatitis B, HBV, Hepatitis, CHB
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis B virus infection with documentation at least 6 months prior to screening
- Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1
- HBV DNA <LLOQ at Screening
- HBsAg between 100 and 5,000 IU/mL at Screening
- Subjects must be HBeAg-negative at Screening
- Fibroscan® result of ≤8.5 kPa within 6 months prior to dosing Day 1
- Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Exclusion Criteria:
- Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening
- History of any clinically significant medical condition associated with chronic liver disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of hepatocellular carcinoma (HCC) at any time
- Contraindications to the use of Peg-IFNα-2a or incapable of self-administration or assisted administration of Peg-IFNα-2a
- Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.
Sites / Locations
- Arizona Liver Health
- Arizona Liver Health
- Research and Education, Inc.
- University of Miami Miller School of Medicine
- Henry Ford Health System
- ID Care
- Nepean Hospital
- St Vincent's Hospital Melbourne
- Prince of Wales Hospital, The Chinese University of Hong Kong
- Queen Mary Hospital
- Pusan National University Hospital
- Asan Medical Center
- Arensia Exploratory Medicine Moldova
- Chia-Yi Christian Hospital
- Chung-Ho Memorial Hospital
- Kaohsiung Chang Gung Memorial Hospital
- Medical Center of Limited Liability Company Harmoniya Krasy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort A, Group 1
Cohort A, Group 2
Cohort B, Group 1
Cohort B, Group 2
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.