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A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

Primary Purpose

Hepatitis B, Chronic

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VIR-3434
VIR-2218
TDF
PEG-IFNα
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female ages 18 or older Chronic HBV infection for >/= 6 months Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation STRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and ≤ 5x ULN THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation History of clinically significant liver disease from non-HBV etiology History or current evidence of hepatic decompensation Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV). History or clinical evidence of alcohol or drug abuse STRIVE and THRIVE: Significant fibrosis or cirrhosis STRIVE and THRIVE: History of immune complex disease STRIVE and THRIVE: History of autoimmune disorder STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 STRIVE: Prior NRTI or PEG-IFN therapy STRIVE: History of known contraindication to any interferon product THRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy

Sites / Locations

  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative SiteRecruiting
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  • Investigative SiteRecruiting
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  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting
  • Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

STRIVE: Cohort 1a (VIR-3434 + TDF)

STRIVE: Cohort 2a (VIR-3434 + TDF)

STRIVE: Cohort 3a (VIR-3434 + TDF)

STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)

STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)

THRIVE: Cohort 1b (VIR-3434 + TDF)

THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)

Arm Description

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total

Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total

Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total

Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks

Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total

Outcomes

Primary Outcome Measures

STRIVE and THRIVE: Proportion of participants achieving suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at the end of treatment

Secondary Outcome Measures

STRIVE and THRIVE: Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
STRIVE and THRIVE: Proportion of participants with serum HBsAg ≤ 10 IU/mL at end of treatment
STRIVE and THRIVE: Proportion of participants with serum HBsAg ≤ 10 IU/mL at 24 weeks post-end of treatment
STRIVE and THRIVE: Serum HBsAg levels and change from baseline across timepoints in the study
STRIVE and THRIVE: Serum HBsAg level at nadir during the study
STRIVE and THRIVE: Time to achieve nadir of serum HBsAg during the study
STRIVE and THRIVE: Time to achieve serum HBsAg loss (< 0.05 IU/mL)
STRIVE and THRIVE: Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
STRIVE: Proportion of participants with HBsAg loss (<0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
STRIVE: For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
STRIVE: Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434
STRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
STRIVE: Proportion of participants achieving HBV DNA (< LLOQ) across timepoints in the study
STRIVE: Proportion of participants achieving ALT ≤ ULN across timepoints in the study
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at 48 weeks
THRIVE: Proportion of participants achieving HBsAg loss (< 0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at 48 weeks
THRIVE: Incidence and titers of ADA (if applicable) to VIR-3434
THRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
THRIVE: Proportion of participants achieving HBV DNA (< LLOQ)

Full Information

First Posted
November 3, 2022
Last Updated
September 27, 2023
Sponsor
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05612581
Brief Title
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
Official Title
A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants With Chronic Hepatitis B Infection (PREVAIL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

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

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.
Detailed Description
VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment. VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STRIVE: Cohort 1a (VIR-3434 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
Arm Title
STRIVE: Cohort 2a (VIR-3434 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks total
Arm Title
STRIVE: Cohort 3a (VIR-3434 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + TDF for 36 or 40 weeks total
Arm Title
STRIVE: Cohort 4a (VIR-3434 + VIR-2218 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 20 or 44 weeks total
Arm Title
STRIVE: Cohort 5a (VIR-3434 + VIR-2218 + TDF + PEG-IFNα)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + VIR-2218 +TDF + PEG-IFNα for 48 weeks total
Arm Title
THRIVE: Cohort 1b (VIR-3434 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + TDF for 44 weeks
Arm Title
THRIVE: Cohort 2b (VIR-3434 + VIR-2218 + TDF)
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with VIR-3434 + VIR-2218 + TDF for 44 weeks total
Intervention Type
Drug
Intervention Name(s)
VIR-3434
Intervention Description
VIR-3434 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)
TDF
Intervention Description
TDF given orally
Intervention Type
Drug
Intervention Name(s)
PEG-IFNα
Intervention Description
PEG-IFNα given by subcutaneous injection
Primary Outcome Measure Information:
Title
STRIVE and THRIVE: Proportion of participants achieving suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) at the end of treatment
Time Frame
Up to 72 weeks
Secondary Outcome Measure Information:
Title
STRIVE and THRIVE: Proportion of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
Up to 96 weeks
Title
STRIVE and THRIVE: Proportion of participants with serum HBsAg ≤ 10 IU/mL at end of treatment
Time Frame
Up to 48 weeks
Title
STRIVE and THRIVE: Proportion of participants with serum HBsAg ≤ 10 IU/mL at 24 weeks post-end of treatment
Time Frame
Up to 72 weeks
Title
STRIVE and THRIVE: Serum HBsAg levels and change from baseline across timepoints in the study
Time Frame
Up to 96 weeks
Title
STRIVE and THRIVE: Serum HBsAg level at nadir during the study
Time Frame
Up to 96 weeks
Title
STRIVE and THRIVE: Time to achieve nadir of serum HBsAg during the study
Time Frame
Up to 96 weeks
Title
STRIVE and THRIVE: Time to achieve serum HBsAg loss (< 0.05 IU/mL)
Time Frame
Up to 96 weeks
Title
STRIVE and THRIVE: Proportion of participants with HBsAg loss with anti-HBs seroconversion at end of treatment and at 24 weeks post-end of treatment
Time Frame
Up to 76 weeks
Title
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
Time Frame
Up to 96 weeks
Title
STRIVE: Proportion of participants with HBsAg loss (<0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
Time Frame
Up to 72 weeks
Title
STRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at the F48 Follow-Up visit
Time Frame
Up to 96 weeks
Title
STRIVE: For HBeAg-positive participants: proportion of participants with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion
Time Frame
Up to 72 weeks
Title
STRIVE: Incidence and titers of anti-drug antibodies (ADA; if applicable) to VIR-3434
Time Frame
Up to 96 weeks
Title
STRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
Time Frame
Up to 96 weeks
Title
STRIVE: Proportion of participants achieving HBV DNA (< LLOQ) across timepoints in the study
Time Frame
Up to 96 weeks
Title
STRIVE: Proportion of participants achieving ALT ≤ ULN across timepoints in the study
Time Frame
Up to 96 weeks
Title
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) with HBsAg loss (< 0.05 IU/mL) after discontinuation of all treatment at 24 weeks and at 48 weeks
Time Frame
Up to 92 weeks
Title
THRIVE: Proportion of participants achieving HBsAg loss (< 0.05 IU/mL) at end of treatment and at 24 weeks post-end of treatment
Time Frame
Up to 44 weeks
Title
THRIVE: Proportion of participants achieving sustained suppression of HBV DNA (< LLOQ) after discontinuation of all treatment at 24 weeks and at 48 weeks
Time Frame
Up to 68 weeks
Title
THRIVE: Incidence and titers of ADA (if applicable) to VIR-3434
Time Frame
Up to 92 weeks
Title
THRIVE: Mean change in serum HBsAg level from baseline across timepoints in the study
Time Frame
Up to 92 weeks
Title
THRIVE: Proportion of participants achieving HBV DNA (< LLOQ)
Time Frame
Up to 92 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ages 18 or older Chronic HBV infection for >/= 6 months Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation STRIVE: HBeAg positive or negative, HBV DNA > 2,000 IU/mL, ALT > ULN and ≤ 5x ULN THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation History of clinically significant liver disease from non-HBV etiology History or current evidence of hepatic decompensation Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV). History or clinical evidence of alcohol or drug abuse STRIVE and THRIVE: Significant fibrosis or cirrhosis STRIVE and THRIVE: History of immune complex disease STRIVE and THRIVE: History of autoimmune disorder STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434 STRIVE: Prior NRTI or PEG-IFN therapy STRIVE: History of known contraindication to any interferon product THRIVE: Prior NRTI therapy < 24 weeks of study or any prior PEG-IFN therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Inquiry
Phone
415-654-5281
Email
clinicaltrials@vir.bio
Facility Information:
Facility Name
Investigative Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Investigative Site
City
Hong Kong
State/Province
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Chisinau
ZIP/Postal Code
MD 2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10334
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Investigative Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigative Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

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