Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

Part of paid clinical trials in Centreville, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT05630820
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 6, 2022
Status verified
May 2026
Primary completion
Nov 3, 2025
Completion
Apr 13, 2026

Study Design

Enrollment
857 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 SiteCentrevilleAlabama35042-
GSK Investigational SiteLos AngelesCalifornia90033-
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteSan FranciscoCalifornia94121-
GSK Investigational SiteColorado SpringsColorado80907-
GSK Investigational SiteFt. PierceFlorida34982-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteGlen BurnieMaryland21061-
GSK Investigational SiteMinneapolisMinnesota55404-
GSK Investigational SitePhiladelphiaPennsylvania19104-
GSK Investigational SiteDenisonTexas75020-
GSK Investigational SiteSeattleWashington98104-

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