A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis

Conditions
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Cirrhosis Due to Hepatitis B

Intervention / Treatment
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* Drug: Entacavir
* Drug: Tenofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (18 years- 70 years) Hbv surface antigen positive > 6 months HbeAg (positive or negative both) Hbv DNA 10^3 ALT ULN No evidence of HCC Platelets count > 30 thousands CTP score > 7 Hepatic encephalopathy (grade 1 - 2 only) No prior Drug resistance Exclusion Criteria: Age < 18 years HCC patients Prior drug resistance Current HE > 2 Solid organ transplantation Inadequate hematological function Co infection with hepatitis C and HIV Autoimmune disorders Pregnancy and Breast feeding Other hepatic diseases Patients on immunosuppressant or chemotherapy agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entacavir<br>Entacavir 0.5 mg (OD) for 48 weeks | Drug: Entacavir<br>* Entacavir-0.5 mg ,OD,for<br>* Other names: ETV;Drug: Tenofovir<br>* Tenofovir ,300 mg,OD,for 48 weeks<br>* Other names: TDF or PMPA;|
| Active Comparator: Tenofovir<br>Tenofovir 300 mg ,OD for 48 weeks | Drug: Entacavir<br>* Entacavir-0.5 mg ,OD,for<br>* Other names: ETV;Drug: Tenofovir<br>* Tenofovir ,300 mg,OD,for 48 weeks<br>* Other names: TDF or PMPA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, cirrhosis, Entacavir, enofovir