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lack of funds
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Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir | Active Comparator |
| |
| Telbivudine | Active Comparator |
| |
| Tenofovir plus Telbivudine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug | 300 mg of Tenofovir daily |
| |
| Telbivudine |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone | 6 Months and 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in serum HBV DNA levels | Baseline and 2 Years | |
| Percentage of patients with ALT normalization | Baseline and 2 Years | |
| Percentage of patients with reduction in HBsAg concentration by >50% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr S. K. Sarin, MD, DM | Institute of Liver & Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | India |
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| Drug |
600 mg of Telbivudine daily |
|
| Tenofovir plus Telbivudine | Drug | Tenofovir (300 mg daily) plus Telbivudine (600 mg daily) |
|
| Baseline and 2 Years |
| Percentage of patients with virological breakthrough | 24 weeks |
| Percentage of patients with primary treatment failure | 12 weeks |
| Occurrence of adverse events | 2 Years |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000077712 | Telbivudine |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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