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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02166047 | Study To Evaluate Safety and Efficacy of Vesatolimod for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Participants | PHASE2 | COMPLETED | 162 | — | — | Jun 30, 2014 | Oct 20, 2016 | Oct 14, 2020 | 23 | United States, Canada +4 |
A mixed effect model for repeated measures (MMRM) was used to analyze HBsAg change from baseline, which included treatment, baseline HBsAg level (\> 5000 IU/mL or ≤ 5000 IU/mL), HBeAg baseline status (positive or negative), visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.
| Arm | Type | Description |
|---|---|---|
| Placebo 4 Weeks (Cohort A) | PLACEBO_COMPARATOR | Placebo tablet once a week for 4 weeks |
| Vesatolimod 1 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 4 weeks |
| Vesatolimod 2 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 4 weeks |
| Vesatolimod 4 mg 4 Weeks (Cohort A) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 4 weeks |
| Placebo 8 Weeks (Cohort B) | PLACEBO_COMPARATOR | Placebo tablet once a week for 8 weeks |
| Vesatolimod 1 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 8 weeks |
| Vesatolimod 2 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 8 weeks |
| Vesatolimod 4 mg 8 Weeks (Cohort B) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 8 weeks |
| Placebo 12 Weeks (Cohort C) | PLACEBO_COMPARATOR | Placebo tablet once a week for 12 weeks |
| Vesatolimod 1 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 1 mg tablet once a week for 12 weeks |
| Vesatolimod 2 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 2 mg tablet once a week for 12 weeks |
| Vesatolimod 4 mg 12 Weeks (Cohort C) | EXPERIMENTAL | Vesatolimod 4 mg tablet once a week for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Vesatolimod | DRUG | Vesatolimod tablet administered orally |
| Placebo | DRUG | Placebo to match vesatolimod tablet administered orally |
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures * Documented evidence of CHB infection (eg, hepatitis B surface antigen \[HBsAg\] positive for more than 6 months) with detectable...