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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01943799 | Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B | PHASE2 | COMPLETED | 178 | — | — | Sep 13, 2013 | Mar 3, 2015 | Nov 1, 2019 | 17 | United States, New Zealand |
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
| Arm | Type | Description |
|---|---|---|
| OAV Alone | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen alone from baseline to Week 48. |
| OAV + GS-4774 2 YU | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20. |
| OAV + GS-4774 10 YU | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20. |
| OAV + GS-4774 40 YU | EXPERIMENTAL | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20. |
| Name | Type | Description |
|---|---|---|
| GS-4774 | BIOLOGICAL | Administered as a subcutaneous injection every 4 weeks for a total of 6 doses |
| OAV Regimen | DRUG | Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination) |
Key Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently taking an approved HBV oral antiviral medication * Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 mo...