Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort 1d VIR-2218 given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
|
Experimental: Cohort 2d VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 3d VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 1e VIR-2218 given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
|
Experimental: Cohort 2e VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 3e VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 1f VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 2f VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Experimental: Cohort 3f VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Drug: pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigative Site | Birtinya | Queensland | Australia | 4575 |
2 | Investigative Site | Fitzroy | Victoria | Australia | 3168 |
3 | Investigative site | Hong Kong | Hong Kong | ||
4 | Investigative Site | Busan | Korea, Republic of | 49241 | |
5 | Investigative Site | Chuncheon | Korea, Republic of | 24253 | |
6 | Investigative Site | Daegu | Korea, Republic of | 41944 | |
7 | Investigative Site | Seoul | Korea, Republic of | 03080 | |
8 | Investigative Site | Seoul | Korea, Republic of | 05505 | |
9 | Investigative Site | Yangsan | Korea, Republic of | 50612 | |
10 | Investigative Site | Batu Caves | Malaysia | 68100 | |
11 | Investigative Site | Kajang | Malaysia | 43000 | |
12 | Investigative Site | Kuala Lumpur | Malaysia | 59100 | |
13 | Investigative Site | Kuantan | Malaysia | 25100 | |
14 | Investigative Site | Auckland | New Zealand | 1010 | |
15 | Investigative Site | Auckland | New Zealand | 2025 | |
16 | Investigative Site | Bangkok | Thailand | 10330 | |
17 | Investigative Site | Bangkok | Thailand | 10400 | |
18 | Investigative Site | Bangkok | Thailand | 10700 | |
19 | Investigative Site | Chiang Mai | Thailand | 50200 | |
20 | Investigative Site | Hat Yai | Thailand | 90110 | |
21 | Investigative Site | Khlong Luang | Thailand | 12120 | |
22 | Investigative Site | Khon Kaen | Thailand | 40002 |
Sponsors and Collaborators
- Vir Biotechnology, Inc.
- Alnylam Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIR-2218-1001-PEG-IFNα