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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00936715 | Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States | PHASE2 | COMPLETED | 24 | — | — | Aug 1, 2009 | Nov 1, 2015 | Jun 2, 2017 | 4 | United States |
| NCT00507689 | Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant | PHASE2 | COMPLETED | 40 | — | — | Sep 1, 2007 | May 1, 2011 | Mar 14, 2014 | 7 | United States |
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.
| Arm | Type | Description |
|---|---|---|
| FTC/TDF | EXPERIMENTAL | - |
| FTC/TDF+HBIg | EXPERIMENTAL | Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. |
| Name | Type | Description |
|---|---|---|
| FTC/TDF | DRUG | 200/300 mg tablet administered orally once daily |
| Hepatitis B Immunoglobulin (HBIg) | DRUG | HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol. |
Key Inclusion Criteria: * Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study. * A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than...