Clinical trial NCT04980482: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis b
Keywords: Hepatitis B virus
Chronic hepatitis B
HBV
Hepatitis
CHB
Lead sponsor: Arbutus Biopharma Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Up to 124 weeks
Secondary outcomes:
measure: Change from baseline in HBsAg and other virologic markers at each time point
timeFrame: Up to 124 weeks
measure: Proportion of subjects with HBsAb seroconversion at each timepoint
timeFrame: Up to 124 weeks
measure: Proportion of subjects who are eligible to stop NA after Week 24 of follow up
timeFrame: Up to 76 weeks
measure: Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria
timeFrame: Up to 124 weeks
measure: 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
timeFrame: Up to 124 weeks
measure: 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
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health
state: Arizona
city: San Diego
country: United States
facility: Research and Education, Inc.
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Republic of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine Moldova
city: Chiayi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Harmoniya Krasy
Study officials:
References: