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

Primary Purpose

Chronic Hepatitis b

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AB-729
Peg-IFNα-2a
Sponsored by
Arbutus Biopharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A, Group 1

Cohort A, Group 2

Cohort B, Group 1

Cohort B, Group 2

Arm Description

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.

Outcomes

Primary Outcome Measures

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-IFNα-2a

Secondary Outcome Measures

Change from baseline in HBsAg and other virologic markers at each time point
Proportion of subjects with HBsAb seroconversion at each timepoint
Proportion of subjects who are eligible to stop NA after Week 24 of follow up
Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria
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
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

Full Information

First Posted
July 19, 2021
Last Updated
January 4, 2023
Sponsor
Arbutus Biopharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04980482
Brief Title
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbutus Biopharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
Hepatitis B virus, Chronic hepatitis B, HBV, Hepatitis, CHB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A, Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort A, Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B, Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B, Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AB-729
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Peg-IFNα-2a
Other Intervention Name(s)
pegylated interferon alpha 2a
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
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-IFNα-2a
Time Frame
Up to 124 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in HBsAg and other virologic markers at each time point
Time Frame
Up to 124 weeks
Title
Proportion of subjects with HBsAb seroconversion at each timepoint
Time Frame
Up to 124 weeks
Title
Proportion of subjects who are eligible to stop NA after Week 24 of follow up
Time Frame
Up to 76 weeks
Title
Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria
Time Frame
Up to 124 weeks
Title
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
Time Frame
Up to 124 weeks
Title
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
Time Frame
Up to 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research and Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Pusan National University Hospital
City
Pusan
State/Province
Republic Of Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Arensia Exploratory Medicine Moldova
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Chia-Yi Christian Hospital
City
Chiayi City
ZIP/Postal Code
60002
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Medical Center of Limited Liability Company Harmoniya Krasy
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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