Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05630807 | Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) | PHASE3 | COMPLETED | 981 | — | — | Dec 7, 2022 | Apr 15, 2026 | May 18, 2026 | 177 | United States, Argentina +24 |
| NCT05630820 | Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2) | PHASE3 | COMPLETED | 857 | — | — | Dec 6, 2022 | Apr 13, 2026 | May 15, 2026 | 171 | United States, Argentina +25 |
The number of participants who achieved FC after discontinuation of all chronic HBV treatment (bepirovirsen/placebo and NA) in the absence of rescue medication will be reported. The FC for HBV is defined as Sustained suppression (24 weeks or longer) of HBV DNA \< Lower limit of quantification (LLOQ) off all HBV treatment and HBsAg not detected with or without HBsAb after a finite duration of therapy.
| Arm | Type | Description |
|---|---|---|
| Bepirovirsen | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bepirovirsen | DRUG | Bepirovirsen will be administered. |
| Placebo | OTHER | Matching placebo will be administered. |
Inclusion Criteria: * Participants who have documented chronic HBV infection ≥6 months prior to screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration...