Phase 2
N=73
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT03576066 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC — 3.48; 3.57; 2.99; 3.35 Log10 International Units (IU)/mL — p=0.6855
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ABI-H0731 (Drug); SOC NUC (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Assembly Biosciences
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC |
3.48; 3.57; 2.99; 3.35; 0.03; 0.03 | 0.6855 |
| PRIMARY Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC |
0.55; 0.43; -0.05; -0.10 | 0.2916 |
| SECONDARY Number of Participants With One or More Adverse Events |
24; 8 | — |
| SECONDARY Number of Participants With Premature Study Discontinuation |
0; 1 | — |
| SECONDARY Number of Participants With One or More Abnormal Safety Laboratory Result |
27; 20 | — |
| 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 + NUC Therapy as Compared With Placebo + NUC Therapy |
1; 0 | — |
| SECONDARY Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy |
0.436; 1390; 1390; 1330; 1330 | — |
| SECONDARY Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
1.10; 1.78; 0.554; 0.346; 0.872; 0.621 | — |
| SECONDARY Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
9.67; 12.2; 13.1; 14.1; 21.3; 11.8 | — |
| SECONDARY Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
77.5; 89.1; 85.5; 76.2; 86.8; 84.1 | — |
| SECONDARY Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy |
— | — |
| SECONDARY Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
— | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- 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
- 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 include:
- Platelet count 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
Data sourced from ClinicalTrials.gov (NCT03576066). 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.