search
Back to results

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Primary Purpose

Chronic Hepatitis B

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VIR-2218
pegylated interferon-alfa 2a
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1d

Cohort 2d

Cohort 3d

Cohort 1e

Cohort 2e

Cohort 3e

Cohort 1f

Cohort 2f

Cohort 3f

Arm Description

VIR-2218 given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection

Outcomes

Primary Outcome Measures

Number of subjects with Adverse Events as assessed by CTCAE v5.0
Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings

Secondary Outcome Measures

Mean maximum reduction of serum HBsAg at any timepoint
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months
Number of subjects with anti-HBs seroconversion at any timepoint
For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint

Full Information

First Posted
May 29, 2020
Last Updated
February 7, 2023
Sponsor
Vir Biotechnology, Inc.
Collaborators
Alnylam Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT04412863
Brief Title
Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.
Collaborators
Alnylam Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1d
Arm Type
Experimental
Arm Description
VIR-2218 given by subcutaneous injection
Arm Title
Cohort 2d
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 3d
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 1e
Arm Type
Experimental
Arm Description
VIR-2218 given by subcutaneous injection
Arm Title
Cohort 2e
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 3e
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 1f
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 2f
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Arm Title
Cohort 3f
Arm Type
Experimental
Arm Description
VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
VIR-2218 given by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
pegylated interferon-alfa 2a
Other Intervention Name(s)
pegylated interferon alpha-2a, PEG-IFNα
Intervention Description
pegylated interferon-alfa 2a given by subcutaneous injection
Primary Outcome Measure Information:
Title
Number of subjects with Adverse Events as assessed by CTCAE v5.0
Time Frame
Up to 148 Weeks
Title
Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
Time Frame
Up to 148 Weeks
Secondary Outcome Measure Information:
Title
Mean maximum reduction of serum HBsAg at any timepoint
Time Frame
Up to 144 Weeks
Title
Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
Time Frame
Up to 144 Weeks
Title
Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months
Time Frame
Up to 144 Weeks
Title
Number of subjects with anti-HBs seroconversion at any timepoint
Time Frame
Up to 144 Weeks
Title
For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
Time Frame
Up to 96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigative Site
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Investigative Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Investigative site
City
Hong Kong
Country
Hong Kong
Facility Name
Investigative Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Investigative Site
City
Chuncheon
ZIP/Postal Code
24253
Country
Korea, Republic of
Facility Name
Investigative Site
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Investigative Site
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Investigative Site
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Investigative Site
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Investigative Site
City
Kuantan
ZIP/Postal Code
25100
Country
Malaysia
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Investigative Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Investigative Site
City
Khlong Luang
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Investigative Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

We'll reach out to this number within 24 hrs