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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000180-13 | Registry Identifier | Eudract |
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The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telbivudine | Experimental | telbivudine 600 mg tablet orally (p.o.) once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with tenofovir 300 mg tablets p.o. once daily for the remaining weeks of treatment. The investigator was to initiate tenofovir add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive telbivudine monotherapy |
|
| tenofovir | Active Comparator | tenofovir 300 mg tablets p.o. once daily for up to 156 weeks. Patients with HBV DNA ≥ 300 copies/mL at Week 24 were to initiate add-on therapy with telbivudine 600 mg tablet p.o. once daily for the remaining weeks of treatment. The investigator was to initiate telbivudine add-on therapy within 2 weeks of central laboratory confirmation. Patients with HBV DNA < 300 copies/mL at Week 24 were to continue to receive tenofovir monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telbivudine | Drug | 600 mg film-coated tablets taken as 600 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - | The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the "treating missing as failure" analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as "missing data." | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance | week 24, 52, 104 |
Not provided
Inclusion Criteria:
Male or female, at least 18 years of age
Documented compensated HBeAg negative CHB defined by all of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Innsbruck | A-6020 | Austria | |||
| Novartis Investigative Site |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | LdT Mono at Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily after Week 24 |
| FG001 | LdT+TDF at Week 24 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment to Week 104 |
|
Not provided
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| tenofovir disoproxil fumarate | Drug | 300 mg tablets taken as 300 mg once daily |
|
| Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline | 156 weeks |
| eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study | eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population. | Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks |
| Vienna |
| 1090 |
| Austria |
| Novartis Investigative Site | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Sofia | 1413 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Sofia | 1527 | Bulgaria |
| Novartis Investigative Site | Varna | 9010 | Bulgaria |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Hamburg | 20099 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Herne | 44623 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Alexandroupoli | Evros | 681 00 | Greece |
| Novartis Investigative Site | Athens | GR | 115 21 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 546 42 | Greece |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Caserta | CE | 81100 | Italy |
| Novartis Investigative Site | Moscow | 111123 | Russia |
| Novartis Investigative Site | Moscow | 119333 | Russia |
| Novartis Investigative Site | Moscow | 119992 | Russia |
| Novartis Investigative Site | Moscow | 127473 | Russia |
| Novartis Investigative Site | Moscow | 129110 | Russia |
| Novartis Investigative Site | Moscow | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Tarragona | Catalonia | 43005 | Spain |
| Novartis Investigative Site | Majadahonda | Madrid | 28222 | Spain |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Diyarbakır | 21280 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| Novartis Investigative Site | Trabzon | 61080 | Turkey (Türkiye) |
Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. |
| FG002 | TDF Mono at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. |
| FG003 | TDF + LdT at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| Completed Wk 24 |
|
| Treatment Exposure ≥ 52 Weeks |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Period Weeks 109-156 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LdT Mono at Week 24 | Patients who had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 continued to receive 600 mg telbivudine daily after Week 24 |
| BG001 | LdT+TDF at Week 24 | Patients who were initially treated with telbivudine and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 600 mg telbivudine daily and additional 300 mg tenofovir after Week 24. |
| BG002 | TDF Mono at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. |
| BG003 | TDF + LdT at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| HBV DNA | Mean | Standard Deviation | log10 copies/mL) |
| |||||||||||||||
| HBV DNA levels < or ≥ 7 log 10 copies/mL at baseline. | Count of Participants | Participants |
| ||||||||||||||||
| Participants with alanine aminotransferase (ALT) - Multiples of upper limits of normal (ULN) | Serum ALT normalization is an important clinically relevant efficacy endpoint. Elevated serum ALT levels are thought to reflect underlying hepatitis disease activity (i.e. active liver inflammation). Correspondingly, ALT normalization is an accepted therapeutic goal in hepatitis studies as it is thought to reflect a substantial reduction in hepatic disease activity.Measurement at baseline. | Count of Participants | Participants |
| |||||||||||||||
| Participants with aspartate aminotransferase (AST) - Multiples of upper limits of normal (ULN) | Measurment at baseline. | Count of Participants | Participants |
|
| 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 | Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - | The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the "treating missing as failure" analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as "missing data." | Roadmap intent-to-treat (rITT) population consisted of patients in the ITT population who did not discontinue before Wk 24 and did not receive add-on. The total of the mono and combination arms were analyzed. | Posted | Number | percentage of participants | week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance | Roadmap intent-to-treat (rITT) population was analyzed. | Posted | Number | 95% Confidence Interval | percentage of particiipants | week 24, 52, 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) | To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline | The modified ITT (mITT) population consisted of all patients in ITT population who were eligible and enrolled into the extension. | Posted | Number | 95% Confidence Interval | percentage of participants | 156 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study | eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population. | Safety population consisted of patients who received at least 1 dose of study drug and had 1 post-baseline safety assessment. Numbers in parentheses represent the number of participants who met the criteria for the measurement in the 2 LDT arms, LDT Overall, 2 TDF arms, TDF Overall, respectively | Posted | Mean | Standard Deviation | mL/min/1.73 m2 | Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks |
|
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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 | LdT Mono at Week 24 | LdT Mono at Week 24 | 6 | 98 | 60 | 98 | ||
| EG001 | LdT + TDF at Week 24 | LdT + TDF at Week 24 | 5 | 22 | 15 | 22 | ||
| EG002 | TDF Mono at Week 24 | TDF Mono at Week 24 | 11 | 109 | 56 | 109 | ||
| EG003 | TDF + LdT at Week 24 | TDF + LdT at Week 24 | 2 | 11 | 8 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastases to abdominal wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Psychogenic pain disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Crystalluria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephroptosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077712 | Telbivudine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Lost to Follow-up |
|
| Administrative problems |
|
| Protocol Violation |
|
| Between 30 and 50 years |
|
| > 50 years |
|
| Male |
|
| ≥ 7 log 10 copies/mL |
|
| > 1 × - < 2 × ULN |
|
| 2 × - < 5 × ULN |
|
| 5 × or more ULN |
|
| > 1 × - < 2 × ULN |
|
| 2 × - < 5 × ULN |
|
| 5 × or more ULN |
|
| Imputing LOCF DNA for Wk 52 |
|
| Imputing within +28d DNA for Wk 52 |
|
Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).
| Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA < 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference. | Difference in percentage | -3.1 | 2-Sided | 95 | -9.4 | 3.1 | Non-Inferiority or Equivalence | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%). |
| Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients | Difference in percentage | -3.8 | 2-Sided | 95 | -7.9 | 0.4 | Non-Inferiority or Equivalence | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%). |
| Imputing within +28d DNA for wk52: d/c for non response <28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure) | Difference in percentage | -2.3 | 2-Sided | 95 | -8.3 | 3.8 | Non-Inferiority or Equivalence | Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%). |
| TDF Mono at Week 24 |
Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. |
| OG004 | TDF + LdT at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| OG005 | TDF Overall | TDF mono and TDF + LdT combined |
|
|
| OG003 |
| TDF Mono at Week 24 |
Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. |
| OG004 | TDF + LdT at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| OG005 | TDF Overall | TDF mono and TDF + LdT combined |
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| OG002 | LdT Overall | Ldt Mono and LdT + TDF combined |
| OG003 | TDF Mono at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid < 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir daily after Week 24. |
| OG004 | TDF + LdT at Week 24 | Patients who were initially treated with tenofovir and had hepatitis B virus deoxyribonucleic acid > 300 copies/mL in their blood at Week 24 and continued to receive 300 mg tenofovir and additional 600 mg telbivudine after Week 24. |
| OG005 | TDF Overall | TDF mono and TDF + LdT combined |
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