Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Phase 2
Active, not recruiting
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: pegylated interferon-alfa 2a
- Registration Number
- NCT04412863
- Lead Sponsor
- Vir Biotechnology, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
- Male or female of ages 18 - 65
- Chronic HBV infection for >/= 6 months
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3e VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 3e pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 2d pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 2e pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 2d VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 2f VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 3d pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 2f pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 1f pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 3f VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 3f pegylated interferon-alfa 2a VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 1f VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 1d VIR-2218 VIR-2218 given by subcutaneous injection Cohort 3d VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection Cohort 1e VIR-2218 VIR-2218 given by subcutaneous injection Cohort 2e VIR-2218 VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
- Primary Outcome Measures
Name Time Method Number of subjects with Adverse Events as assessed by CTCAE v5.0 Up to 148 Weeks Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings Up to 148 Weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Investigative Site
🇹ðŸ‡Khon Kaen, Thailand
Investigative site
ðŸ‡ðŸ‡°Hong Kong, Hong Kong