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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00116805 | A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B | PHASE3 | COMPLETED | 266 | — | — | Jun 1, 2005 | Jan 1, 2016 | Mar 9, 2017 | 87 | United States, Australia +13 |
| NCT00117676 | A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B | PHASE3 | COMPLETED | 382 | — | — | Feb 1, 2005 | Jan 1, 2016 | Mar 7, 2017 | 80 | United States, Australia +13 |
| NCT02579382 | Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated | PHASE2 | COMPLETED | 192 | — | — | Nov 10, 2015 | May 3, 2019 | May 18, 2020 | 21 | United States, Canada +6 |
Complete response was a composite endpoint defined as histological response and HBV DNA \< 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40.
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (\> 19 vs ≤ 19 IU/L for females; \> 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
| Arm | Type | Description |
|---|---|---|
| TDF-TDF | EXPERIMENTAL | TDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. |
| ADV-TDF | ACTIVE_COMPARATOR | ADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period. |
| TDF + placebo | PLACEBO_COMPARATOR | Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 1 mg | EXPERIMENTAL | Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 2 mg | EXPERIMENTAL | Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 4 mg | EXPERIMENTAL | Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| Name | Type | Description |
|---|---|---|
| TDF | DRUG | 300 mg tablet administered orally once daily |
| ADV | DRUG | 10 mg tablet administered orally once daily |
| TDF placebo | DRUG | Tablet administered orally once daily |
| ADV placebo | DRUG | Tablet administered orally once daily |
| FTC/TDF | DRUG | 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily |
| Vesatolimod | DRUG | Tablets administered orally once a week (every 7 days) for 12 doses |
| Placebo | DRUG | Placebo administered orally once a week (every 7 days) for 12 doses |
Key Inclusion Criteria: A patient must meet all of the following inclusion criteria to be eligible for participation in this study: * Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months * 18 through 69 years of age, inclusive * ...