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

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: CKD-390; Drug: viread

Study type: Interventional

Funder types: Industry

Identifiers

NCT02805738

163HBV15036

Details and patient eligibility

About

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

Full description

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).

Enrollment: 158 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. male or female older than 19 years at the time of screening
2. Patients who have chronic hepatitis B disease are taken Viried for 6 months
3. Patients who show HBV DNA undetected(less than 20 IU/mL)
4. Patients who show positive HBsAg
5. Patients who show positive HBeAg or negative HBeAg
6. 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

1. Patients who are not taken any anti-viral agents except Viread Tab

2. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)

3. 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

4. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL

5. Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation

6. Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study

7. Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome

8. Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption

9. History of malignant tumor within 5 years

10. Patients who take any other investigational product within 30 days

11. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial

12. Pregnant, breast-feeding and childbearing age who don't use adequate contraception

13. Patients who receive an organ transplant or bone marrow transplant or are going to received surgury

14. History of allergic reaction to the investigational product

15. Patients that investigators consider ineligible for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Drug: CKD-390

Active comparator Group

Active Comparator group

Description:

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

Treatment:

Drug: viread