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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01651403 | Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection | PHASE3 | ACTIVE NOT_RECRUITING | 90 | — | — | Dec 6, 2012 | Jul 1, 2027 | Jan 30, 2026 | 21 | United States, India +3 |
| NCT00507507 | A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT) | PHASE2 | COMPLETED | 126 | — | — | Sep 1, 2007 | Aug 1, 2012 | Jul 17, 2015 | 45 | United States, Australia +9 |
| NCT00307489 | Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil | PHASE2 | COMPLETED | 106 | — | — | Mar 1, 2006 | Oct 1, 2010 | Nov 1, 2011 | 28 | United States, France +2 |
The percentage of participants with HBV DNA \< 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
| Arm | Type | Description |
|---|---|---|
| Tenofovir DF (Blinded Randomized Treatment) | EXPERIMENTAL | Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). |
| Placebo to match TDF (Blinded Randomized Treatment) | PLACEBO_COMPARATOR | Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). |
| Tenofovir DF (Open-label Treatment) | EXPERIMENTAL | Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3). |
| Tenofovir DF (Open-label Extension Phase) | EXPERIMENTAL | Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight. |
| Tenofovir DF | EXPERIMENTAL | Participants were randomized to receive tenofovir DF plus placebo to match FTC once daily. |
| FTC+Tenofovir DF | EXPERIMENTAL | Participants were randomized to receive FTC plus tenofovir DF once daily. |
| 1 | EXPERIMENTAL | TDF |
| 2 | EXPERIMENTAL | FTC/TDF |
| Name | Type | Description |
|---|---|---|
| Tenofovir DF | DRUG | * Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg. |
| TDF Placebo | DRUG | * Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily. |
| FTC | DRUG | Emtricitabine (FTC) 200 mg capsule taken orally once daily |
| Placebo | DRUG | Placebo to match FTC taken once daily |
| emtricitabine /tenofovir DF | DRUG | emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet) |
Key Inclusion Criteria: * Male or Female, 2 to \< 12 years of age * Weight ≥ 10 kg * Chronic HBV infection ≥ 6 months * Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative * HBV Viral Load ≥ 100,000 copies/mL * Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at...