A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
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Lead
Assembly Biosciences
This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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 \<100,000/mm3
* Albumin \<lower limit of normal (LLN)
* Direct bilirubin \>1.2×upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \>10×ULN at screening
Clareo Health | A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
