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| ID | Type | Description | Link |
|---|---|---|---|
| NCT03780543 | Registry Identifier | ClinicalTrials.gov identifier |
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Sponsor decision
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Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to 100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect on biomarkers of sustained viral response (SVR) (NCT03780543).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBeAg-negative Subjects from Parent Study ABI-H0731-201 | Active Comparator | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care (SOC) nucleos(t)ide (NrtI)-suppressed and HBeAg-negative will receive both ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years. |
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| HBeAg-positive Subjects from Parent Study ABI-H0731-201 | Active Comparator | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
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| Subjects from Parent Study ABI-H0731-202 | Active Comparator | Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) | Drug | Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Viral Response (SVR) at 24 Weeks Off Treatment | To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy. SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24. | Completing from week 52 until week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Incidence of treatment emergent adverse events (AEs) | Up to Week 148 |
| Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Anderson | Assembly Biosciences Inc. | Study Director |
| M. F. Yuen, MD, PhD, DSc | The University of Hong Kong | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Beverly Hills | California | 90211 | United States | ||
| Southern California Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38510983 | Derived | Yuen MF, Fung S, Ma X, Nguyen TT, Hassanein T, Hann HW, Elkhashab M, Nahass RG, Park JS, Jacobson IM, Ayoub WS, Han SH, Gane EJ, Zomorodi K, Yan R, Ma J, Knox SJ, Stamm LM, Bonacini M, Weilert F, Ramji A, Bennett M, Ravendhran N, Chan S, Dieterich DT, Kwo PY, Schiff ER, Bae HS, Lalezari J, Agarwal K, Sulkowski MS. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses. JHEP Rep. 2024 Jan 18;6(4):100999. doi: 10.1016/j.jhepr.2023.100999. eCollection 2024 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2020 | Dec 16, 2022 |
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To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS) To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS |
| EOT: up to Week 52 or 148; EOS: up to 3 years off treatment |
| Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy | Incidence of subjects with suppression/loss of viral Hepatitis B "e" antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy | upto Week 148 |
| Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy | Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment | Up to Week 148 |
| Coronado |
| California |
| 92118 |
| United States |
| Coalition of Inclusive Medicine | Los Angeles | California | 90057 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Research and Education | San Diego | California | 92115 | 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 | 11355 | 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 |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto Liver Center | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| University of Hong Kong, Queen Mary Hospital | Hong Kong | Hong Kong |
| Auckland Clinical Studies | Auckland | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| King's College London | London | United Kingdom |
| FG001 | Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. |
| FG002 | HBeAg Positive Participants From Parent Study ABI-H0731-202 | Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir alafenamide (TAF) tablet QD orally as per approved package insert. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. |
| BG001 | Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. |
| BG002 | HBeAg Positive Participants From Parent Study ABI-H0731-202 | Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Number of Participants | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number of Participants in each location. | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m 2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Viral Response (SVR) at 24 Weeks Off Treatment | To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy. SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24. | Participants who met the protocol-specific treatment action criteria to discontinue treatment with ABI-H0731 and NrtI after completing 52 weeks of treatment were analyzed for sustained viral repones at 24 weeks off treatment. (i.e., Completing from week 52 (treatment discharge) until week 76 (24 weeks off treatment) | Posted | Count of Participants | Participants | Completing from week 52 until week 76 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Events | Incidence of treatment emergent adverse events (AEs) | Safety population included all who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Week 148 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS) | To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS) To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS | Number/proportion of subjects with normal alanine aminotransferase (ALT) at end of treatment (EOT) and end of study (EOS) | Posted | Count of Participants | Participants | EOT: up to Week 52 or 148; EOS: up to 3 years off treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy | Incidence of subjects with suppression/loss of viral Hepatitis B "e" antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy | The proportion of subjects with hepatitis B virus (HBV) DNA target not detected (TND). Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column. | Posted | Count of Participants | Participants | upto Week 148 |
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| Secondary | Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy | Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment | Subjects from the parent study 201 with positive or negative Hepatitis B "e" antigen (HBeAg) Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column. | Posted | Count of Participants | Participants | Up to Week 148 |
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Up to Week 148
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. | 0 | 26 | 0 | 26 | 5 | 26 |
| EG001 | Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201 | Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. | 0 | 43 | 0 | 43 | 12 | 43 |
| EG002 | HBeAg Positive Participants From Parent Study ABI-H0731-202 | Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks. ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally. SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert. | 0 | 23 | 1 | 23 | 4 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| fatique | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Development Officer | Assembly BioSciences Inc. | 415-855-3006 | manderson@assemblybio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2021 | Dec 16, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C413685 | entecavir |
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
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| Hong Kong |
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| United States |
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| United Kingdom |
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| Units |
|---|
| Counts |
|---|
| Participants |
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Treatment-naïve subjects with Hepatitis B "e" antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)
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