Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet

Study Overview
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Brief Summary
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A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

Detailed Description
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A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).

Official Title
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A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: CKD-390
* Drug: viread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female older than 19 years at the time of screening Patients who have chronic hepatitis B disease are taken Viried for 6 months Patients who show HBV DNA undetected(less than 20 IU/mL) Patients who show positive HBsAg Patients who show positive HBeAg or negative HBeAg Patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent Exclusion Criteria: Patients who are not taken any anti-viral agents except Viread Tab Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV) Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening total bilirubin > Upper normal limit x 1.5 prothrombin time(INR) > Upper normal limit x 1.5 platelets < 75,000/ul serum albumin < 3.0g/dl Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption History of malignant tumor within 5 years Patients who take any other investigational product within 30 days Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial Pregnant, breast-feeding and childbearing age who don't use adequate contraception Patients who receive an organ transplant or bone marrow transplant or are going to received surgury History of allergic reaction to the investigational product Patients that investigators consider ineligible for this study

Ages Eligible for Study
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Minimum Age: 19 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: Experimental Group<br>once a time per a day, CKD-390 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks | Drug: CKD-390<br>* CKD-390 1 Tablet (48 weeks)<br>* Other names: Tenofovir disoproxil aspartate 308.04mg;|
| Active Comparator: Active comparator Group<br>once a time per a day, Viread 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks | Drug: viread<br>* viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)<br>* Other names: Tenofovir disoproxil fumarate 300mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) |  | 24weeks after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) |  | 12, 36, 48 weeks after drug administration | 
| The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level |  | 12, 24, 36, 48 weeks after drug administration | 
| The rate of subjects who had normal ALT result |  | 12, 24, 36, 48weeks after drug administration | 
| The rate of subjects who showed HBeAg loss |  | 24, 48 weeks after drug administration | 
| The rate of subjects who showed HBeAg seroconversion |  | 24, 48 weeks after drug administration | 
| The rate of subjects who showed HBsAg loss |  | 24, 48 weeks after drug administration | 
| The rate of subjects who showed HBsAg seroconversion |  | 24, 48 weeks after drug administration | 
| The rate of subjects who showed Virologic breakthrough |  | 12, 24, 36, 48 weeks after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis B, tenofovir, CKD-390