CLINICAL TRIALS PROFILE FOR ABI-H0731

Clinical Trials for ABI-H0731

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02908191 ↗	A Study in Healthy Volunteers and Patients With Chronic Hepatitis B	Completed	Assembly Biosciences	Phase 1	This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.
NCT03109730 ↗	Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B	Completed	Assembly Biosciences	Phase 1/Phase 2	The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.
NCT03576066 ↗	A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection	Completed	Assembly Biosciences	Phase 2	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).
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)	Completed	Assembly Biosciences	Phase 2	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)
NCT03780543 ↗	A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients	Terminated	Assembly Biosciences	Phase 2	Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
NCT04454567 ↗	A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors	Terminated	Assembly Biosciences	Phase 2	This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
NCT04781647 ↗	A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection	Recruiting	Assembly Biosciences	Phase 2	The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)

Clinical Trial Conditions for ABI-H0731

Condition Name

Condition Name
Intervention	Trials
Chronic Hepatitis B	8

Condition MeSH

Condition MeSH
Intervention	Trials
Hepatitis B	8
Hepatitis A	8
Hepatitis	8
Hepatitis, Chronic	8

Clinical Trial Locations for ABI-H0731

Trials by Country

Trials by Country
Location	Trials
United States	29
Canada	8
China	7
New Zealand	6
Australia	6

Trials by US State

Trials by US State
Location	Trials
New York	4
New Jersey	4
Maryland	4
California	4
Pennsylvania	4

Clinical Trial Progress for ABI-H0731

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	6
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Recruiting	2
Terminated	2

Clinical Trial Sponsors for ABI-H0731

Sponsor Name

Sponsor Name
Sponsor	Trials
Assembly Biosciences	8
Arbutus Biopharma Corporation	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	9