A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
NCT ID: NCT03577171
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2018-06-19
2019-06-21
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 ETV
Participants with cHBV who are currently not being treated will receive ABI-H0731 along with SOC ETV 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 300mg QD of ABI-H0731 tablets orally.
SOC ETV
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo + SOC ETV
Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally 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 ETV
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet
Participants will receive matching QD placebo tablets orally.
Interventions
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ABI-H0731
Participants will receive 300mg QD of ABI-H0731 tablets orally.
SOC ETV
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tablet
Participants will receive matching QD placebo tablets orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBeAg-positive at screening
* In good general health except for cHBV
* HBV viral load ≥2×105 IU/mL
* Hepatitis B surface antigen (HBsAg) \>1000 IU/mL at screening
Exclusion Criteria
* 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
* Exclusionary laboratory parameters at screening:
* Platelet count \<100,000/mm3
* Albumin \<lower limit of normal (LLN)
* Direct bilirubin \>1.2×upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \>10×ULN at screening
* Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is \>ULN but \<100 ng/mL, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible HCC
* 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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Southern California Research Center
Coronado, California, United States
Asia Pacific Liver Center
Los Angeles, California, United States
Research and Education
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
NYU Langone Health
New York, New York, United States
Xiaoli Ma MD
Philadelphia, Pennsylvania, United States
GI Research Institute
Vancouver, British Columbia, Canada
Toronto Liver Center
Toronto, Ontario, Canada
University of Hong Kong, Queen Mary Hospital
Hong Kong, , Hong Kong
Waikato Hospital
Hamilton, , New Zealand
King's College London
London, , United Kingdom
Countries
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References
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Sulkowski MS, 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, Yuen MF. Safety and efficacy of vebicorvir administered with entecavir in treatment-naive patients with chronic hepatitis B virus infection. J Hepatol. 2022 Nov;77(5):1265-1275. doi: 10.1016/j.jhep.2022.05.027. Epub 2022 Jun 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABI-H0731-202
Identifier Type: -
Identifier Source: org_study_id
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