Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04980482
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Arbutus Biopharma Corporation

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: AB-729 Drug: Peg-IFNα-2a Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 29, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : August 2024


Arm Intervention/treatment
Experimental: Cohort A, Group 1

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.

Drug: AB-729
subcutaneous injection

Drug: Peg-IFNα-2a
subcutaneous injection
Other Name: pegylated interferon alpha 2a

Experimental: Cohort A, Group 2

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.

Drug: AB-729
subcutaneous injection

Drug: Peg-IFNα-2a
subcutaneous injection
Other Name: pegylated interferon alpha 2a

Experimental: Cohort B, Group 1

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.

Drug: AB-729
subcutaneous injection

Drug: Peg-IFNα-2a
subcutaneous injection
Other Name: pegylated interferon alpha 2a

Experimental: Cohort B, Group 2

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.

Drug: AB-729
subcutaneous injection

Drug: Peg-IFNα-2a
subcutaneous injection
Other Name: pegylated interferon alpha 2a




Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline in HBsAg and other virologic markers at each time point [ Time Frame: Up to 124 weeks ]
  2. Proportion of subjects with HBsAb seroconversion at each timepoint [ Time Frame: Up to 124 weeks ]
  3. Proportion of subjects who are eligible to stop NA after Week 24 of follow up [ Time Frame: Up to 76 weeks ]
  4. Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria [ Time Frame: Up to 124 weeks ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04980482


Contacts
Layout table for location contacts
Contact: Arbutus Biopharma 267-469-0914 clinicaltrials@arbutusbio.com

Locations
Layout table for location information
United States, California
Huntington Medical Research Institutes Liver Center Recruiting
Pasadena, California, United States, 91105
Contact: Myron J Tong         
Principal Investigator: Myron J Tong         
Research and Education, Inc. Recruiting
San Diego, California, United States, 92105
Contact: Tuan Nguyen         
Principal Investigator: Tuan Nguyen         
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Kaylan Bhamidimarri, MD         
Principal Investigator: Kaylan Bhamidimarri         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stuart Gordon         
Principal Investigator: Stuart Gordon         
United States, New Jersey
ID Care Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Ronald Nahass, MD         
Principal Investigator: Ronald Nahass, MD         
Australia, New South Wales
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Martin Weltman         
Principal Investigator: Martin Weltman         
Australia, Victoria
St Vincent's Hospital Melbourne Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Jacinta Holmes         
Principal Investigator: Jacinta Holmes         
Hong Kong
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Grace Lai-Hung Wong         
Principal Investigator: Grace Lai-Hung Wong         
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Man Fung Yuen         
Principal Investigator: Man Fung Yuen         
Korea, Republic of
Pusan National University Hospital Recruiting
Pusan, Republic Of Korea, Korea, Republic of, 49241
Contact: Jeong Heo         
Principal Investigator: Jeong Heo         
Moldova, Republic of
Arensia Exploratory Medicine Moldova Recruiting
Chisinau, Moldova, Republic of, 2025
Contact: Tatiana Burda         
Principal Investigator: Tatiana Burda         
Taiwan
Chia-Yi Christian Hospital Recruiting
Chiayi City, Taiwan, 60002
Contact: Chi-Yi Chen         
Principal Investigator: Chi-Yi Chen         
Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
Contact: Wan-Long Chuang         
Principal Investigator: Wan-Long Chuang         
Ukraine
Medical Center of Limited Liability Company Harmoniya Krasy Active, not recruiting
Kyiv, Ukraine, 01135
Sponsors and Collaborators
Arbutus Biopharma Corporation
Layout table for additonal information
Responsible Party: Arbutus Biopharma Corporation
ClinicalTrials.gov Identifier: NCT04980482    
Other Study ID Numbers: AB-729-201
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arbutus Biopharma Corporation:
Hepatitis B virus
Chronic hepatitis B
HBV
Hepatitis
CHB
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs