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The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA)
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This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. |
|
| Adefovir monotherapy | Active Comparator | Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telbivudine | Drug | 600mg/day oral tablet for 96 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Who Experienced Virologic Breakthrough | Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit. | 96 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration | Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment. | Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks |
| Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria |
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Inclusion Criteria:
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | San Diego | California | United States | |||
One patient was randomized but never received study drug treatment because he was discontinued on the randomization day due to sponsor request.
Planned enrollment was 150 patients. At the time of study termination, 43 patients had been enrolled and randomized to study treatment and 42 patients received study drug (21 patients in the combination group and 21 in the monotherapy group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. |
| FG001 | Adefovir Monotherapy | Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. |
| BG001 | Adefovir Monotherapy | Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Participants Who Experienced Virologic Breakthrough | Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit. | This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed. | Posted | Number | Proportion of participants | 96 Weeks |
|
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Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Therapy | Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000077712 | Telbivudine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| adefovir dipivoxil |
| Drug |
10 mg of adefovir by mouth once daily |
|
Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb. |
| 12 week, 24 week, 48 week and 60 weeks |
| Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough | The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed. | Week 96 |
| San Mateo |
| California |
| United States |
| Pok Fu Lam | Hong Kong |
| Seoul | South Korea |
| Novarits | Kaohsuing | Taiwan |
| Bangkok | Thailand |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Adefovir Monotherapy |
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. |
|
| Secondary | Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration | Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment. | Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation. | Posted | Mean | Standard Deviation | Log10 Copies/mL | Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria | Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb. | Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint. | Posted | Number | Percentage of participants | 12 week, 24 week, 48 week and 60 weeks |
|
|
|
| Secondary | Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough | The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed. | Posted | Number | Proportion of Participants | Week 96 |
|
|
| 1 |
| 21 |
| 14 |
| 21 |
| EG001 | Adefovir Monotherapy | Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. | 0 | 21 | 11 | 21 |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Change from Baseline to Week 12 |
|
| At Baseline (N = 20, 20) |
|
| At Week 24 |
|
| Change from Baseline to Week 24 |
|
| At Baseline (N = 13, 9) |
|
| At Week 48 |
|
| Change from Baseline to Week 48 |
|
| At Baseline (N = 2, 3) |
|
| At Week 60 |
|
| Change from Baseline to Week 60 |
|
| Undetectable HBV DNA at week 48 |
|
| Undetectable HBV DNA at week 60 |
|
| Serum ALT normalization at week 12 |
|
| Serum ALT normalization at week 24 |
|
| Serum ALT normalization at week 48 |
|
| Serum ALT normalization at week 60 |
|
| HBeAg loss at week 12 |
|
| HBeAg loss at week 24 |
|
| HBeAg loss at week 48 |
|
| HBeAg loss at week 60 |
|
| HBeAg seroconversion at week 12 |
|
| HBeAg seroconversion at week 24 |
|
| HBeAg seroconversion at week 48 |
|
| HBeAg seroconversion at week 60 |
|
| HBsAg loss at week 12 |
|
| HBsAg loss at week 24 |
|
| HBsAg loss at week 48 |
|
| HBsAg loss at week 60 |
|
| HBsAg seroconversion at week 12 |
|
| HBsAg seroconversion at week 24 |
|
| HBsAg seroconversion at week 48 |
|
| HBsAg seroconversion at week 60 |
|