Chronic Hepatitis B
Conditions
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
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.
Interventions
DRUGVIR-2218
VIR-2218 given by subcutaneous injection
pegylated interferon-alfa 2a given by subcutaneous injection
Sponsors
Vir Biotechnology, Inc.
Alnylam Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Maximum Reduction of Serum HBsAg at Any Timepoint | Up to 148 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 | — |
| Proportion of Subjects With Anti-HBs Seroconversion at Any Timepoint | Up to 148 Weeks | Anti-HBs seroconversion is defined as Anti-HBs quantitative value changed from baseline \<LLOQ (5 mIU/mL) to post-baseline\>=LLOQ. |
| For HBeAg-positive Patients: Proportion of Subjects With HBeAg Loss (Undetectable HBeAg) and/or Anti-HBe Seroconversion at Any Timepoint | Up to 148 weeks | — |
Countries
Australia, Hong Kong, Malaysia, New Zealand, South Korea, Thailand
Participant flow
Recruitment details
Phase 1 Part1 A-C data results are posted on clinicaltrials.gov in NCT03672188.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hepatitis B surface antigen (Log10 IU/mL) | 3.28 Log10 IU/mL STANDARD_DEVIATION 0.726 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment Australia | 1 Participants |
| Region of Enrollment Hong Kong | 10 Participants |
| Region of Enrollment Malaysia | 0 Participants |
| Region of Enrollment New Zealand | 15 Participants |
| Region of Enrollment South Korea | 7 Participants |
| Region of Enrollment Thailand | 13 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 5 | 0 / 18 | 0 / 18 | 0 / 13 |
| other Total, other adverse events | 9 / 15 | 13 / 15 | 3 / 5 | 16 / 18 | 17 / 18 | 13 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 5 | 1 / 18 | 1 / 18 | 1 / 13 |
Outcome results
None listed