Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate. In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks

Detailed Description
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Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase. The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .

Official Title
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Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Tenofovir Disoproxil Fumarate
* Drug: Tenofovir Disoproxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months. HBeAg negative and HBeAb positive at screening Exclusion Criteria: Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study. Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) Significant renal, cardiovascular, pulmonary, or neurological disease currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 69 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
Interventional Model Description: Open-label, randomized, Parallel
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir Disoproxil<br>Tenofovir Disoproxil 245mg, a daily dose for 48 weeks | Drug: Tenofovir Disoproxil<br>* Virehepa 245mg<br>* Other names: Virehepa;|
| Placebo Comparator: Tenofovir Disoproxil Fumarate<br>Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks | Drug: Tenofovir Disoproxil Fumarate<br>* Viread 300mg<br>* Other names: Viread;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA inhibition | plasma HBV DNA level of less than 400 copies per milliliter | 48weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viral suppression | an HBV DNA level of <400 copies per milliliter | 24weeks |