A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 14
- 主要终点
- Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
研究概览
简要总结
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.
详细描述
The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 65 years of age
- •Chronic HBV infection
- •Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg
排除标准
- •Seropositive for HIV, HCV, or HDV antibody at Screen
- •Previous treatment with any investigational HBV antiviral treatments within the last 6 months
- •Other known cause of liver disease, including NASH
- •Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention
研究组 & 干预措施
Cohort B1
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B1
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B2
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B2
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B3
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B3
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B4
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B4
ABI-H0731 or Placebo in varying doses by mouth for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
干预措施: Entecavir (Drug)
Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: ABI-H0731 (Drug)
Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: Placebo for ABI-H0731 (Drug)
Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
干预措施: Pegasys (Drug)
结局指标
主要结局
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
时间窗: Up to 57 days
次要结局
未报告次要终点