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The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir + Telbivudine | Experimental | Tenofovir (300 mg/day) plus telbivudine (600 mg/day). |
|
| Tenofovir | Active Comparator | In tenofovir arm subjects will receive tenofovir (300 mg) once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir + Telbivudine | Drug | Tenofovir (300 mg/day) plus telbivudine (600 mg/day). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 1 and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in HBV DNA. | 7 days, 15 days, 1 month and 3 month | |
| Drug(s) related adverse effects/ side effects | 1 and 3 months | |
| Improvement in CTP and MELD scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiv Kumar Sarin, DM | Institute of Liver & Biliary Sciences (ILBS). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Tenofovir |
| Drug |
In tenofovir arm subjects will receive tenofovir (300 mg) once daily. |
|
| 1 and 3 months |
| Alteration of renal functions | 1 and 3 months |
| 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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