A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 21
- 主要终点
- Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
研究概览
简要总结
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).
详细描述
This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 <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
研究组 & 干预措施
ABI-H0731 + SOC NUC
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.
干预措施: ABI-H0731 (Drug)
ABI-H0731 + SOC NUC
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.
干预措施: SOC NUC (Drug)
Placebo + SOC NUC
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.
干预措施: SOC NUC (Drug)
Placebo + SOC NUC
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.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
时间窗: Baseline to Week 24
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
时间窗: Baseline to Week 24
次要结局
- Number of Participants With One or More Abnormal Safety Laboratory Result(Up to Week 36)
- Number of Participants With a Clinically-significant Electrocardiogram Abnormality(Up to Week 24)
- Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy(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(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(Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24)
- Number of Participants With Premature Study Discontinuation(Up to Follow-up (maximum up to Week 36))
- Number of Participants With a Clinically-significant Change in Vital Signs(Baseline and up to Week 24)
- Number of Participants With One or More Adverse Events(Up to Follow-up (maximum up to Week 36))
- 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(Baseline to Week 24)
- Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy(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(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(Baseline, Weeks 2, 4, 12, and 24)