A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 23
- 主要终点
- Number of subjects with Adverse Events as assessed by CTCAE v5.0
研究概览
简要总结
This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 of ages 18 - 65
- •Chronic HBV infection for >/= 6 months
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- •Significant fibrosis or cirrhosis
- •History or evidence of drug or alcohol abuse
- •History of intolerance to SC injection
- •History of chronic liver disease from any cause other than chronic HBV infection
- •History of hepatic decompensation
- •Any prior receipt of an interferon product
研究组 & 干预措施
Cohort 2d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 1f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 3e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 3d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 2e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 1f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 2f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 3f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: pegylated interferon-alfa 2a (Drug)
Cohort 3e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 2f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 3f
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 1d
VIR-2218 given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 3d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 2d
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 1e
VIR-2218 given by subcutaneous injection
干预措施: VIR-2218 (Drug)
Cohort 2e
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
干预措施: VIR-2218 (Drug)
结局指标
主要结局
Number of subjects with Adverse Events as assessed by CTCAE v5.0
时间窗: Up to 148 Weeks
Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
时间窗: Up to 148 Weeks
Number of Subjects With Abnormalities in Vital Signs, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings
时间窗: Up to 148 Weeks
Number of Subjects With Adverse Events as Assessed by CTCAE v5.0
时间窗: Up to 148 Weeks
次要结局
- Mean maximum reduction of serum HBsAg at any timepoint(Up to 144 Weeks)
- Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint(Up to 144 Weeks)
- Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months(Up to 144 Weeks)
- Number of subjects with anti-HBs seroconversion at any timepoint(Up to 144 Weeks)
- For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint(Up to 96 weeks)
- Proportion of Subjects With Serum HBsAg Loss (Undetectable HBsAg) at Any Timepoint(Up to 148 Weeks)
- Proportion of Subjects With Sustained Serum HBsAg Loss (Undetectable HBsAg) for Greater Than 6 Months(Up to 148 Weeks)
- Mean Maximum Reduction of Serum HBsAg at Any Timepoint(Up to 148 Weeks)
- Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint(Up to 148 Weeks)
- For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint(Up to 148 weeks)