Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients

Detailed Description
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DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.

Official Title
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Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients

Conditions
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Hepatitis B， Chronic

Intervention / Treatment
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* Drug: DA-2802
* Drug: Viread®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis B aged 18 years or older Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit Subjects who have HBsAg positive test at screening visit Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening Exclusion Criteria: Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus Subjects with creatinine clearance of less than 50 ml/min at the screening visit At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma Subjects with decompensated liver disease who meet the following criteria: Total bilirubin levels greater than 2.5 mg/dl Prothrombin time is at least 3 seconds longer than normal upper limit Serum albumin value less than 30 g/l Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-2802<br>DA-2802 319mg tablet qd | Drug: DA-2802<br>* DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.<br>* Other names: tenofovir disoproxil orotate;|
| Active Comparator: Viread®<br>Viread® 300mg tablet qd | Drug: Viread®<br>* Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.<br>* Other names: tenofovir disoproxil fumarate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of HBV DNA level(log10) |  | Change from baseline at 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects HBV DNA < 400 copies/ml |  | at 24 weeks, 48 weeks | 
| Percentage of subjects who had normal ALT levels |  | at 24 week, 48 week | 
| Percentage of subjects who experienced loss of HBeAg |  | at 24 week, 48 week |