Chronic Hepatitis BPhase 2NCT03576066

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

A Phase 2 study testing ABI-H0731 and SOC NUC in people with Chronic Hepatitis B, run by Assembly Biosciences at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: ABI-H0731 and SOC NUC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 21 sitesin 3 countries
Study dates: 11 Jun 2018to 5 Jul 2019
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female between ages 18 and 70 years
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

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

United States17 sites

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Digestive Disease Associates
Catonsville, Maryland, 21228
Southern California Research Center
Coronado, California, 92118
Sing Chan, MD
Flushing, New York, 11354
Infectious Disease Care
Hillsborough, New Jersey, 08844
Asia Pacific Liver Center
Los Angeles, California, 90057
University of California Los Angeles
Los Angeles, California, 90095
University of Miami Hospital and Clinics
Miami, Florida, 33136
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Xiaoli Ma, MD
Philadelphia, Pennsylvania, 19107
Research and Education
San Diego, California, 92105
Medical Associates Research Group
San Diego, California, 92123
Quest Clinical Research
San Francisco, California, 94115
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

Canada3 sites

Toronto General Hospital
Toronto
Toronto Liver Center
Toronto
GI Research Institute
Vancouver

Other trials in Canada

New Zealand1 site

Auckland City Hospital
Auckland

Other trials in New Zealand

About this study

Official title: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B

Read the detailed description

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.

Conditions: Chronic Hepatitis B
Being tested: ABI-H0731, SOC NUC, Placebo Oral Tablet
Keywords: Chronic hepatitis B, HBV, HBeAg-positive, hepatitis B, HBeAg-negative, vebicorvir, VBR
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-H0731Drug
Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
SOC NUCDrug
Also called Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF)
Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
Placebo Oral TabletDrug
Participants will receive placebo matching ABI-0731 tablets orally QD.

Study groups in NCT03576066
Study group	Role	What they receive
ABI-H0731 + SOC NUC	Experimental	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. Receives: Drug: ABI-H0731; Drug: SOC NUC
Placebo + SOC NUC	Active comparator	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. Receives: Drug: SOC NUC; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Measured: Baseline to Week 24
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Measured: Baseline to Week 24

Secondary outcomes (12)

Number of Participants With One or More Adverse Events
Measured: Up to Follow-up (maximum up to Week 36)
Number of Participants With Premature Study Discontinuation
Measured: Up to Follow-up (maximum up to Week 36)
Number of Participants With One or More Abnormal Safety Laboratory Result
Measured: Up to Week 36
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Measured: Up to Week 24
Number of Participants With a Clinically-significant Change in Vital Signs
Vital signs assessed were body temperature, respiratory rate, and pulse rate
Measured: Baseline and up to Week 24
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).
Measured: Baseline to Week 24
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Measured: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Measured: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Measured: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Measured: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Measured: Baseline, Weeks 2, 4, 12, and 24
Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Measured: Baseline, Weeks 2, 4, 12, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 20185 Jul 2019

First posted3 Jul 2018
Study start11 Jun 2018
Primary completion5 Jul 2019
Study completion5 Jul 2019

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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03576066
Sponsor's protocol ID: ABI-H0731-201
Status last verified: Jan 2021
First submitted: 6 Jun 2018
Last updated: 17 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 35460726

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT03576066
Acronym / sponsor ID: ABI-H0731-201
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B, HBV, HBeAg-positive, hepatitis B, HBeAg-negative, vebicorvir, VBR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Assembly BiosciencesIndustry (pharma, biotech, devices)
Study start: 11 Jun 2018 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 3 Jul 2018 (actual)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ABI-H0731 + SOC NUC	Experimental	Drug: ABI-H0731, Drug: SOC NUCVirologically 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.
Placebo + SOC NUC	Active comparator	Drug: SOC NUC, Drug: Placebo Oral TabletVirologically 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female between ages 18 and 70 years
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

Key exclusion criteria (13 listed)

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)

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-H0731Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).	Drug	ABI-H0731 + SOC NUC
SOC NUCAlso: Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), Tenofovir alafenamide (TAF)Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.	Drug	ABI-H0731 + SOC NUC, Placebo + SOC NUC
Placebo Oral TabletParticipants will receive placebo matching ABI-0731 tablets orally QD.	Drug	Placebo + SOC NUC

Primary outcome

Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24

12 secondary outcomes

Number of Participants With One or More Adverse Events
Time frame: Up to Follow-up (maximum up to Week 36)
Number of Participants With Premature Study Discontinuation
Time frame: Up to Follow-up (maximum up to Week 36)
Number of Participants With One or More Abnormal Safety Laboratory Result
Time frame: Up to Week 36
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Time frame: Up to Week 24
Number of Participants With a Clinically-significant Change in Vital Signs
Time frame: Baseline and up to Week 24
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
Time frame: Baseline to Week 24
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24
Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABI-H0731 + SOC NUC	45	45
Placebo + SOC NUC	28	27

Primary outcome: Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

Time frame: Baseline to Week 24. Mean (Standard Deviation). Unit: Log10 International Units (IU)/mL

Measure	HBeAg-positive Participants: ABI-H0731 + SOC NUC n = 29	HBeAg-positive Participants: Placebo + SOC NUC n = 18	HBeAg-negative Participants: ABI-H0731 + SOC NUC n = 16	HBeAg-negative Participants: Placebo + SOC NUC n = 10
Baseline	3.48 (0.401)	3.57 (0.516)	2.99 (0.555)	3.35 (0.648)
Change from baseline	0.03 (0.138)	0.03 (0.054)	0.09 (0.133)	-0.00 (0.021)

HBeAg-positive Participants: ABI-H0731 + SOC NUC vs HBeAg-positive Participants: Placebo + SOC NUC: p = 0.6855, Repeated measures analysis
HBeAg-negative Participants: ABI-H0731 + SOC NUC vs HBeAg-negative Participants: Placebo + SOC NUC: p = 0.1750, Repeated measures analysis

Population analysed: Intention-to-treat (ITT) population: all randomized participants. Results were analyzed and reported based on Baseline HBeAg status: positive or negative, for available data at Baseline, Week 24, or both.

Primary outcome: Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC

Time frame: Baseline to Week 24. Mean (Standard Deviation). Unit: Log10 International Units (IU)/mL

Measure	HBeAg-positive Participants: ABI-H0731 + SOC NUC n = 29	HBeAg-positive Participants: Placebo + SOC NUC n = 18
Baseline	0.55 (0.980)	0.43 (0.964)
Change from baseline	-0.05 (0.191)	-0.10 (0.193)

HBeAg-positive Participants: ABI-H0731 + SOC NUC vs HBeAg-positive Participants: Placebo + SOC NUC: p = 0.2916, Repeated measures analysis

Population analysed: ITT population. Results were analyzed and reported only for participants who were HBeAg positive at Baseline and had available data at Baseline, Week 24, or both.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 36. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABI-H0731 + SOC NUC	0 of 45 (0%)	24 of 45 (53.3%)	0 of 45
Placebo + SOC NUC	0 of 28 (0%)	8 of 28 (28.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35460726Yuen 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.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
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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.

The record lists no contact. Use the official record to reach the sponsor.

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-H0731 and SOC NUC in people with Chronic Hepatitis B, run by Assembly Biosciences at 21 sites in 3 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 13 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: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada, New Zealand. 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. 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 28 Jan 2021). 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?

Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03576066, which also lists 1 linked publication.

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 17 Feb 2021.