Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT05630807
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Hepatitis B
  • Hepatitis B, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bepirovirsen — DRUG
    Bepirovirsen will be administered.
  • Placebo — OTHER
    Matching placebo will be administered.

Study Details

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to \[≥\] 100 international unit per milliliter \[IU/mL\] to less than or equal \[≤\]1000 IU/mL or greater than \[\>\] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

Key Dates

Start date
Dec 7, 2022
Status verified
May 2026
Primary completion
Nov 11, 2025
Completion
Apr 15, 2026

Study Design

Enrollment
981 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bepirovirsen
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of participants achieving functional cure (FC) with baseline HBsAg ≤3000 IU/mL [ Time Frame: Up to 72 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteChandlerArizona85224-
GSK Investigational SiteDavisCalifornia95817-
GSK Investigational SiteLos AngelesCalifornia90027-
GSK Investigational SitePalo AltoCalifornia94304-
GSK Investigational SiteSan JoseCalifornia95116-
GSK Investigational SiteLittletonColorado80120-
GSK Investigational SiteMiamiFlorida33134-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteBaltimoreMaryland21287-
GSK Investigational SiteDetroitMichigan48377-
GSK Investigational SiteRichmondVirginia23249-
GSK Investigational SiteRichmondVirginia23298-

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