Phase 2 N=25 Randomized Triple-blind Treatment

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Chronic Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT03577171 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: 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 — 7.91; 8.03; -4.45; -3.30 Log10 International Units (IU)/mL — p=0.0077

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ABI-H0731 (Drug); SOC ETV (Drug); Placebo Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Assembly Biosciences
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	7.91; 8.03; -4.45; -3.30; -5.33; -4.20	0.0077 sig
SECONDARY Number of Participants One or More Adverse Events	7; 5	—
SECONDARY Number of Participants With Premature Study Discontinuation	0; 0	—
SECONDARY Number of Participants With One or More Abnormal Safety Laboratory Result	8; 10	—
SECONDARY Number of Participants With a Clinically-significant Electrocardiogram Abnormality	0; 0	—
SECONDARY Number of Participants With a Clinically-significant Change in Vital Signs	0; 0	—
SECONDARY 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	4; 2	—
SECONDARY 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	0; 0; 0; 0; 0; 0	—
SECONDARY Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV	—	—
SECONDARY Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV	1; 1; 12; 11	—
SECONDARY Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy	NA; 1480; 1290; 1270; 1470	—
SECONDARY Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy	0.00325; 0; 0.432; 0.497; 0.419; 0.618	—
SECONDARY Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy	—	—
SECONDARY Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy	—	—

Summary

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)

Eligibility Criteria

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 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 1.5×ULN
Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03577171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.