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Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entacavir | Active Comparator | Entacavir 0.5 mg (OD) for 48 weeks |
|
| Tenofovir | Active Comparator | Tenofovir 300 mg ,OD for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entacavir | Drug | Entacavir-0.5 mg ,OD,for |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy | EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome | Death | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr mohammad sadik Memon, Fcps gastro | Contact | 022-232593 | Sadikmemon@gmail.com | |
| Madiha Zaki, MSC gastro | Contact | 022-232593 | Madiyaah@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad sadik Memon, Fcps gastro | AIMS Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of medical Sciences | Recruiting | Hyderābād | Sindh | 71800 | Pakistan |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir | Drug | Tenofovir ,300 mg,OD,for 48 weeks |
|
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |