- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577171
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
January 8, 2021 updated by: Assembly Biosciences
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B
The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 2K5
- GI Research Institute
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Ontario
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Toronto, Ontario, Canada, M6H 3M1
- Toronto Liver Center
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Hong Kong, Hong Kong
- University of Hong Kong, Queen Mary Hospital
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Hamilton, New Zealand
- Waikato Hospital
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London, United Kingdom
- King's College London
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California
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Coronado, California, United States, 92118
- Southern California Research Center
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Los Angeles, California, United States, 90057
- Asia Pacific Liver Center
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San Diego, California, United States, 92105
- Research and Education
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San Francisco, California, United States, 94115
- Quest Clinical Research
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Xiaoli MA MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Male or female between ages 18 and 70 years
- 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
Key Exclusion Criteria:
- Any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4 weeks
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Participants will receive 300mg QD of ABI-H0731 tablets orally.
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Other Names:
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Experimental: 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.
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Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Other Names:
Participants will receive matching QD placebo tablets orally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time Frame: Baseline, Week 12, and Week 24
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Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0.
The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
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Baseline, Week 12, and Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants One or More Adverse Events
Time Frame: Up to Follow-up (maximum up to Week 36)
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Up to Follow-up (maximum up to Week 36)
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Number of Participants With Premature Study Discontinuation
Time Frame: Up to Follow-up (maximum up to Week 36)
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Up to Follow-up (maximum up to Week 36)
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Number of Participants With One or More Abnormal Safety Laboratory Result
Time Frame: Up to Week 36
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Up to Week 36
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Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Time Frame: Up to Week 24
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Up to Week 24
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Number of Participants With a Clinically-significant Change in Vital Signs
Time Frame: Baseline and up to Week 24
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Vital signs assessed were body temperature, respiratory rate, and pulse rate
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Baseline and up to Week 24
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Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time Frame: Baseline to Week 24
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Baseline to Week 24
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Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
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HBV DNA was measured using COBAS TaqMan Version 2.0.
The LLOQ was 20 IU/mL and the LOD was 10 IU/mL.
The number of participants with HBV DNA below the limit of quantitation (<20 IU/mL) and target detected (≥10 IU/mL) was assessed.
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Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
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Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV
Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
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Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.
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Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
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Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time Frame: Up to Week 36
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Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.
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Up to Week 36
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Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
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Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
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Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time Frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
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Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
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Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy
Time Frame: Baseline, Weeks 2, 4, 12, and 24
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Baseline, Weeks 2, 4, 12, and 24
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Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time Frame: Baseline, Weeks 2, 4, 12, 24, and 28
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Baseline, Weeks 2, 4, 12, 24, and 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2018
Primary Completion (Actual)
June 21, 2019
Study Completion (Actual)
June 21, 2019
Study Registration Dates
First Submitted
June 6, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 8, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Entecavir
Other Study ID Numbers
- ABI-H0731-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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