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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00410202 | Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus | PHASE3 | COMPLETED | 629 | — | — | Mar 1, 2008 | Jul 1, 2012 | Nov 21, 2013 | 67 | United States, Australia +16 |
| NCT00395018 | Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection | PHASE3 | COMPLETED | 109 | — | — | Apr 1, 2007 | Mar 1, 2011 | May 31, 2012 | 32 | United States, Argentina +7 |
| NCT00410072 | Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B | PHASE3 | COMPLETED | 669 | — | — | Apr 1, 2007 | Oct 1, 2010 | Mar 15, 2013 | 68 | United States, Argentina +11 |
| NCT00423891 | A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection | PHASE1 | COMPLETED | 64 | — | — | Jun 30, 2007 | Sep 4, 2017 | May 2, 2018 | 19 | United States, Argentina +6 |
HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (\<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed.
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
HBV DNA levels \<50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.
| Arm | Type | Description |
|---|---|---|
| Entecavir | ACTIVE_COMPARATOR | With the option of adding tenofovir at week 48. (This does not apply to Korea) |
| Adefovir + Lamivudine | ACTIVE_COMPARATOR | - |
| Entecavir + Adefovir | ACTIVE_COMPARATOR | - |
| TDF 0.5 mg | EXPERIMENTAL | TDF=tenofovir |
| ETV 0.5 mg +TDF 300 mg | EXPERIMENTAL | ETV=entecavir; TDF=tenofovir |
| Arm 1: Entecavir | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Entecavir | DRUG | Tablets, Oral, 1mg, once daily, 100 weeks |
| Tenofovir | DRUG | Tablets, Oral, 300 mg, once daily |
| Adefovir | DRUG | Tablets, Oral, 10mg, once daily, 100 weeks |
| Lamivudine | DRUG | Tablets, Oral, 100mg, once daily, 100 weeks |
| Entecavir + Tenofovir | DRUG | Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks |
Inclusion Criteria: * Evidence of lamivudine (LVD) resistance * Subjects must have a history of previous LVD treatment at screening, and must have evidence of at least 1 LVD resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (M204V/I/S) * Nucleoside- and nucl...