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NCT04412863 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04412863
Other study ID # VIR-2218-1001-PEG-IFNa
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 3, 2020
Est. completion date November 2024

Study information
Verified date May 2024
Source Vir Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 84
Est. completion date November 2024
Est. primary completion date March 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• VIR-2218
VIR-2218 given by subcutaneous injection
• pegylated interferon-alfa 2a
pegylated interferon-alfa 2a given by subcutaneous injection

Locations
Country Name City State
Australia Investigative Site Birtinya Queensland
Australia Investigative Site Fitzroy Victoria
Hong Kong Investigative site Hong Kong
Korea, Republic of Investigative Site Busan
Korea, Republic of Investigative Site Chuncheon
Korea, Republic of Investigative Site Daegu
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Seoul
Korea, Republic of Investigative Site Yangsan
Malaysia Investigative Site Batu Caves
Malaysia Investigative Site Kajang
Malaysia Investigative Site Kuala Lumpur
Malaysia Investigative Site Kuantan
New Zealand Investigative Site Auckland
New Zealand Investigative Site Auckland
Thailand Investigative Site Bangkok
Thailand Investigative Site Bangkok
Thailand Investigative Site Bangkok
Thailand Investigative Site Chiang Mai
Thailand Investigative Site Hat Yai
Thailand Investigative Site Khlong Luang
Thailand Investigative Site Khon Kaen

Sponsors (2)
Lead Sponsor Collaborator
Vir Biotechnology, Inc. Alnylam Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Hong Kong,  Korea, Republic of,  Malaysia,  New Zealand,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects with Adverse Events as assessed by CTCAE v5.0 Up to 148 Weeks
Primary Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings Up to 148 Weeks
Secondary Mean maximum reduction of serum HBsAg at any timepoint Up to 144 Weeks
Secondary Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint Up to 144 Weeks
Secondary Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months Up to 144 Weeks
Secondary Number of subjects with anti-HBs seroconversion at any timepoint Up to 144 Weeks
Secondary For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint Up to 96 weeks
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