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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01300234 | Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB) | PHASE3 | COMPLETED | 512 | — | — | Mar 30, 2011 | Dec 6, 2016 | Jul 13, 2018 | 20 | China |
The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) \<400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Arm | Type | Description |
|---|---|---|
| A (TDF tablets) | EXPERIMENTAL | Tenofovir disoproxil fumarate (TDF) tablets |
| B (ADV tablets) | ACTIVE_COMPARATOR | Adefovir dipivoxil (ADV) tablets |
| Name | Type | Description |
|---|---|---|
| Tenofovir disoproxil fumarate (TDF) tablets | DRUG | white, almond-shaped, film-coated tablets containing 300mg of TDF |
| Adefovir dipivoxil (ADV) tablets | DRUG | white to off-white, round, biconvex tablets containing 10mg of ADV |
Inclusion Criteria: * HBeAg positive/negative CHB with blood HBVDNA≥10\^5 copies/mL and elevated ALT * Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed in less than 10% of the total study population Exclusion Criteria: * subjects with hepatocellular carcinoma...