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Nucleos(t)ide Analogue

AB-729 + Pegylated Interferon for Chronic Hepatitis B

Phase 2
Waitlist Available
Research Sponsored by Arbutus Biopharma Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 124 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to treat hepatitis B. The drug is being given with other drugs that are used to treat hepatitis B. The trial is testing how safe and effective the new drug is.

Who is the study for?
This trial is for adults with chronic hepatitis B who've been on specific antiviral drugs for at least a year, have low HBV DNA levels, are HBeAg-negative, and have liver scarring within safe limits. It's not open to those with other viral infections like HIV or conditions suggesting advanced liver disease.Check my eligibility
What is being tested?
The study tests the safety and virus-fighting ability of AB-729 combined with ongoing antiviral therapy and short courses of Peg-IFNα-2a in people with chronic hepatitis B. Participants will be chosen randomly to receive this combination treatment.See study design
What are the potential side effects?
Potential side effects may include flu-like symptoms, fatigue, headache, fever from Peg-IFNα-2a; AB-729's side effects aren't fully known but could involve reactions at the injection site or changes in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on TAF, TDF, or ETV for at least 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 124 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 124 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
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
Proportion of subjects who are eligible to stop NA after Week 24 of follow up
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort B, Group 2Experimental Treatment2 Interventions
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.
Group II: Cohort B, Group 1Experimental Treatment2 Interventions
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.
Group III: Cohort A, Group 2Experimental Treatment2 Interventions
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.
Group IV: Cohort A, Group 1Experimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Arbutus Biopharma CorporationLead Sponsor
12 Previous Clinical Trials
629 Total Patients Enrolled

Media Library

AB-729 (Nucleos(t)ide Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT04980482 — Phase 2
Chronic Hepatitis B Research Study Groups: Cohort B, Group 2, Cohort A, Group 1, Cohort A, Group 2, Cohort B, Group 1
Chronic Hepatitis B Clinical Trial 2023: AB-729 Highlights & Side Effects. Trial Name: NCT04980482 — Phase 2
AB-729 (Nucleos(t)ide Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04980482 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become a part of this research?

"This study is looking for 40 participants that currently have hepatitis and meet the following eligibility criteria: 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, 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, Chronic"

Answered by AI

If an elderly person meets the other requirements, are they allowed to participate in this research?

"In order to participate in this trial, patients must be aged between 18-60. There are a total of 34 clinical trials for people under the age of 18 and 269 trials for seniors above 65."

Answered by AI

How many test subjects are in this trial?

"That is correct. The most recent information on clinicaltrials.gov says that this trial is looking for 40 patients at 7 different hospitals or clinics. The study was started on 10/29/2021 and the last update to the posting was on 11/10/2022."

Answered by AI

What is the research history of AB-729?

"AB-729 was first studied in the year 1998 at Nova Scotia Cancer Centre. So far there are 141 completed trials. There are currently 27 active studies, with a large number of these trials being performed out of San Diego, California."

Answered by AI

Are patients being accepted into the trial at this time?

"That is correct. The clinicaltrials.gov website notes that this research trial is open for recruitment. It was originally posted on October 29th, 2021 and last updated November 10th, 2022. Presently, the study requires 40 individuals from 7 different locations."

Answered by AI

What are the side effects of AB-729?

"While there is some data supporting AB-729's safety, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI

How many different geographical areas are included in this trial?

"Research and Education, Inc. in San Diego, California is one of the primary locations where this trial is taking place. Other sites include ID Care in Hillsborough, New jersey and Henry Ford Health System in Detroit, Michigan. Answer: This study does not have a control group because it is an open-label design which means that all participants will receive the study medication.Rewritten Answer: Because this research project uses an open-label design-- meaning every participant receives the study medication-- there is no control group."

Answered by AI

What medical conditions is AB-729 commonly used to treat?

"AB-729 is most commonly used as an intervention for renal cell carcinoma. It can also be taken to treat other conditions including viral hepatitis b, non-hodgkin's lymphoma, lymphoma, follicular, melanoma, and malignant neoplasms."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What site did they apply to?
ID Care
Research and Education, Inc.
Huntington Medical Research Institutes Liver Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
2021. "Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04980482.
All > Autoimmune Hepatitis > Hepatitis B
~1 spots leftby May 2024
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