A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B
1 other identifier
interventional
73
3 countries
21
Brief Summary
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2018
CompletedStudy Start
First participant enrolled
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2019
CompletedResults Posted
Study results publicly available
January 28, 2021
CompletedFebruary 17, 2021
January 1, 2021
1.1 years
June 6, 2018
January 8, 2021
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Baseline to Week 24
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Baseline to Week 24
Secondary Outcomes (12)
Number of Participants With One or More Adverse Events
Up to Follow-up (maximum up to Week 36)
Number of Participants With Premature Study Discontinuation
Up to Follow-up (maximum up to Week 36)
Number of Participants With One or More Abnormal Safety Laboratory Result
Up to Week 36
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Up to Week 24
Number of Participants With a Clinically-significant Change in Vital Signs
Baseline and up to Week 24
- +7 more secondary outcomes
Study Arms (2)
ABI-H0731 + SOC NUC
EXPERIMENTALVirologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
Placebo + SOC NUC
ACTIVE COMPARATORVirologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
Interventions
Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Participants will receive placebo matching ABI-0731 tablets orally QD.
Eligibility Criteria
You may qualify if:
- Male or female between ages 18 and 70 years
- Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy
- HBeAg-positive or HBeAg-negative at screening
- In good general health except for cHBV
You may not qualify if:
- Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)
- History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
- Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study
- Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening
- History of hepatocellular carcinoma (HCC)
- Females who are lactating or pregnant or wish to become pregnant are excluded from the study
- Platelet count \<100,000/mm3
- Albumin \<lower limit of normal (LLN)
- Direct bilirubin \>1.2×upper limit of normal (ULN)
- Alanine aminotransferase (ALT) \>5×ULN at screening
- International Normalized Ratio (INR) \>1.5×ULN
- Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Cedars-Sinai Medical Center
Beverly Hills, California, 90211, United States
Southern California Research Center
Coronado, California, 92118, United States
Asia Pacific Liver Center
Los Angeles, California, 90057, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Research and Education
San Diego, California, 92105, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Digestive Disease Associates
Catonsville, Maryland, 21228, United States
Infectious Disease Care
Hillsborough, New Jersey, 08844, United States
Sing Chan, MD
Flushing, New York, 11354, United States
NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Xiaoli Ma, MD
Philadelphia, Pennsylvania, 19107, United States
Toronto General Hospital
Toronto, Canada
Toronto Liver Center
Toronto, Canada
GI Research Institute
Vancouver, Canada
Auckland City Hospital
Auckland, New Zealand
Related Publications (1)
Yuen MF, Agarwal K, Ma X, Nguyen TT, Schiff ER, Hann HL, Dieterich DT, Nahass RG, Park JS, Chan S, Han SB, Gane EJ, Bennett M, Alves K, Evanchik M, Yan R, Huang Q, Lopatin U, Colonno R, Ma J, Knox SJ, Stamm LM, Bonacini M, Jacobson IM, Ayoub WS, Weilert F, Ravendhran N, Ramji A, Kwo PY, Elkhashab M, Hassanein T, Bae HS, Lalezari JP, Fung SK, Sulkowski MS. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection. J Hepatol. 2022 Sep;77(3):642-652. doi: 10.1016/j.jhep.2022.04.005. Epub 2022 Apr 20.
PMID: 35460726DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Bahr, Sr. Director, Clinical Operations
- Organization
- Assembly Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
July 3, 2018
Study Start
June 11, 2018
Primary Completion
July 5, 2019
Study Completion
July 5, 2019
Last Updated
February 17, 2021
Results First Posted
January 28, 2021
Record last verified: 2021-01