EICHORCondition: Chronic Hepatitis B · Hepatitis B, Chronic · Sponsor: GlaxoSmithKline
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| GSK Investigational Site | Centreville, Alabama, United States | — |
| GSK Investigational Site | Los Angeles, California, United States | — |
| GSK Investigational Site | San Francisco, California, United States | — |
| GSK Investigational Site | San Francisco, California, United States | — |
| GSK Investigational Site | Colorado Springs, Colorado, United States | — |
| GSK Investigational Site | Ft. Pierce, Florida, United States | — |
| GSK Investigational Site | Miami, Florida, United States | — |
| GSK Investigational Site | Glen Burnie, Maryland, United States | — |
| GSK Investigational Site | Minneapolis, Minnesota, United States | — |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States | — |
| GSK Investigational Site | Denison, Texas, United States | — |
| GSK Investigational Site | Seattle, Washington, United States | — |
+ 159 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05630820