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 Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04980482
• Other study ID #: AB-729-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 29, 2021
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Arbutus Biopharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: April 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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-IFNa-2a or incapable of self-administration or assisted administration of Peg-IFNa-2a
• Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• AB-729
subcutaneous injection
• Peg-IFNa-2a
subcutaneous injection

Locations

Country	Name	City	State
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria
Hong Kong	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Korea, Republic of	Pusan National University Hospital	Pusan	Republic Of Korea
Korea, Republic of	Asan Medical Center	Seoul
Moldova, Republic of	Arensia Exploratory Medicine Moldova	Chisinau
Taiwan	Chia-Yi Christian Hospital	Chiayi City
Taiwan	Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Ukraine	Medical Center of Limited Liability Company Harmoniya Krasy	Kyiv
United States	Arizona Liver Health	Chandler	Arizona
United States	Henry Ford Health System	Detroit	Michigan
United States	ID Care	Hillsborough	New Jersey
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Research and Education, Inc.	San Diego	California
United States	Arizona Liver Health	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arbutus Biopharma Corporation

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  Korea, Republic of,  Moldova, Republic of,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities after dosing with AB-729 plus Peg-IFNa-2a		Up to 124 weeks
Secondary	Change from baseline in HBsAg and other virologic markers at each time point		Up to 124 weeks
Secondary	Proportion of subjects with HBsAb seroconversion at each timepoint		Up to 124 weeks
Secondary	Proportion of subjects who are eligible to stop NA after Week 24 of follow up		Up to 76 weeks
Secondary	Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria		Up to 124 weeks
Secondary	Proportion of subjects who discontinue NA and subsequently meet protocol defined clinical relapse criteria. Proportion of subjects who discontinue NA and subsequently meet protocol defined viral relapse criteria		Up to 124 weeks
Secondary	Post-dose plasma concentrations of AB-729 anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at selected timepoints		Up to 40 weeks