A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
NCT ID: NCT03576066
Last Updated: 2021-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2018-06-11
2019-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABI-H0731 + SOC NUC
Virologically 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.
ABI-H0731
Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Placebo + SOC NUC
Virologically 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.
SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Placebo Oral Tablet
Participants will receive placebo matching ABI-0731 tablets orally QD.
Interventions
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ABI-H0731
Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
SOC NUC
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Placebo Oral Tablet
Participants will receive placebo matching ABI-0731 tablets orally QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Exclusionary laboratory parameters at screening include:
* 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
18 Years
70 Years
ALL
No
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center
Beverly Hills, California, United States
Southern California Research Center
Coronado, California, United States
Asia Pacific Liver Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Research and Education
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Digestive Disease Associates
Catonsville, Maryland, United States
Infectious Disease Care
Hillsborough, New Jersey, United States
Sing Chan, MD
Flushing, New York, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Xiaoli Ma, MD
Philadelphia, Pennsylvania, United States
Toronto General Hospital
Toronto, , Canada
Toronto Liver Center
Toronto, , Canada
GI Research Institute
Vancouver, , Canada
Auckland City Hospital
Auckland, , New Zealand
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABI-H0731-201
Identifier Type: -
Identifier Source: org_study_id
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