Chronic Hepatitis BPhase 2NCT04398134
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
A Phase 2 study testing ABI-H2158 and Entecavir (ETV) in people with Chronic Hepatitis B, run by Assembly Biosciences at 44 sites in 9 countries.
Trial summary
This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ABI-H2158 and Entecavir (ETV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 28 Aug 2020to 28 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg
- HBeAg ≥500 IU/mL at Screening
- In good general health except for chronic HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart
- Lack of cirrhosis or advanced liver disease
Who cannot join
- Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
- History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
- History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
United States13 sites
Johns Hopkins University
Baltimore, Maryland, 21287
New Discovery, LLC
Flushing, New York, 11355
Coalition of Inclusive Medicine
Los Angeles, California, 90020
Northwell Health Center for Liver Disease
Manhasset, New York, 11030
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, 33136
NYU Langone Health
New York, New York, 10016
California Liver Research Institute
Pasadena, California, 91105
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Stanford University Medical Center
Redwood City, California, 94063
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Research and Education Inc.
San Diego, California, 92105
Quest Clinical Research
San Francisco, California, 94115
University of Washington
Seattle, Washington, 98104
Australia7 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120
Alfred Hospital
Melbourne, Victoria, 3004
John Hunter Hospital
New Lambton, New South Wales, 2305
Melbourne Health
Parkville, Victoria, 3050
South Korea7 sites
Pusan National University Hospital
Busan, 49241
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
SMG-SNU Boramae Medical Center
Seoul, 07061
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
China5 sites
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital Central South University
Changsha, 410008
The Second Affliated Hospital of Chongqing Medical University
Chongqing, Yuzhong District, 400010
Nanfang Hospital
Guangzhou, 510515
Guangzhou Eighth People's Hospital - Guangzhou Infectious Diseases Hospital
Guangzhou
Taiwan5 sites
Kaohsiung Medical University Hospital
Kaohsiung City, Sanmin District, 80756
China Medical University Hospital
Taichung, 44047
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital Taipei Branch
Taipei, 10449
Chang Gung Memorial Hospital (CGMH) - Linkou Branch
Taoyuan, 333
Canada2 sites
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
New Zealand2 sites
Auckland Clinical Studies
Auckland, 2105
Waikato Hospital
Hamilton, 3240
About this study
Official title: A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.
- Conditions
- Chronic Hepatitis B
- Being tested
- ABI-H2158, Placebo, Entecavir (ETV)
- Keywords
- HBV, hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-H2158Drug
3 X 100 mg tablets for oral administration
PlaceboDrug
Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV)Drug
0.5 mg tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| ABI-H2158 plus ETV | Experimental | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Receives: Drug: ABI-H2158; Drug: Entecavir (ETV) |
| Placebo plus ETV | Placebo comparator | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Receives: Drug: Placebo; Drug: Entecavir (ETV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Measured: Up to 72 weeks
Percentage of Participants With Premature Treatment Discontinuation
Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely.
Measured: Up to 72 weeks
Change From Baseline in Mean log10 HBV DNA
HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only.
Measured: Baseline and Week 24
Percentage of Participants With Abnormal Laboratory Results
Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days.
Measured: Up to 72 weeks
Secondary outcomes (13)
Trough Plasma Concentration of ABI-H2158
Measured: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158
Measured: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Trough Plasma Concentration of ETV
Measured: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ETV
Measured: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV
Measured: up to Week 72
Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation
Measured: Up to 72 weeks
Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation
Measured: Up to 72 weeks
Change From Baseline in Serum HBV Surface Antigen (HBsAg)
Measured: Baseline and up to 72 weeks
Change From Baseline in Serum HBV "e" Antigen (HBeAg)
Measured: Baseline and up to 72 weeks
Change From Baseline in Serum HBV Core-related Antigen (HBcrAg)
Measured: Baseline and up to 72 weeks
Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV
Measured: Baseline and up to Week 24
Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158
Measured: Up to 72 weeks
Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start28 Aug 2020
- Primary completion14 Oct 2021
- Study completion28 Dec 2021
Why it stopped: Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grace Wang, Study director, Assembly Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398134
- Sponsor's protocol ID
- ABI-H2158-201
- Other IDs
- 2019-004902-85, 2019
- Status last verified
- Aug 2022
- First submitted
- 18 May 2020
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT04398134
- Acronym / sponsor ID
- ABI-H2158-201
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV, hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 26 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI-H2158 plus ETV | Experimental | Drug: ABI-H2158, Drug: Entecavir (ETV)ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks |
| Placebo plus ETV | Placebo comparator | Drug: Placebo, Drug: Entecavir (ETV)Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg
- HBeAg ≥500 IU/mL at Screening
- In good general health except for chronic HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart
- Lack of cirrhosis or advanced liver disease
Key exclusion criteria (3 listed)
- Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
- History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
- History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-H21583 X 100 mg tablets for oral administration | Drug | ABI-H2158 plus ETV |
| PlaceboSugar pill manufactured to mimic the ABI-H2158 tablets | Drug | Placebo plus ETV |
| Entecavir (ETV)0.5 mg tablet for oral administration | Drug | ABI-H2158 plus ETV, Placebo plus ETV |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: Up to 72 weeks
Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Percentage of Participants With Premature Treatment Discontinuation
Time frame: Up to 72 weeks
Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely.
Change From Baseline in Mean log10 HBV DNA
Time frame: Baseline and Week 24
HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only.
Percentage of Participants With Abnormal Laboratory Results
Time frame: Up to 72 weeks
Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days.
13 secondary outcomes
Trough Plasma Concentration of ABI-H2158
Time frame: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158
Time frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Trough Plasma Concentration of ETV
Time frame: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ETV
Time frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV
Time frame: up to Week 72
Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation
Time frame: Up to 72 weeks
Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation
Time frame: Up to 72 weeks
Change From Baseline in Serum HBV Surface Antigen (HBsAg)
Time frame: Baseline and up to 72 weeks
Change From Baseline in Serum HBV "e" Antigen (HBeAg)
Time frame: Baseline and up to 72 weeks
Change From Baseline in Serum HBV Core-related Antigen (HBcrAg)
Time frame: Baseline and up to 72 weeks
Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV
Time frame: Baseline and up to Week 24
Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158
Time frame: Up to 72 weeks
Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint
Time frame: up to 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Wang study director
Assembly Biosciences
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABI-H2158 and Entecavir (ETV) in people with Chronic Hepatitis B, run by Assembly Biosciences at 44 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Australia, South Korea, China, Taiwan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: Up to 72 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.