Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B, tenofovir, CKD-390
Brief summary
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet
Detailed 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).
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) | 24weeks after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 HBV DNA undetected (less than 20IU/mL) | 12, 36, 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 |
| The rate of subjects who showed HBeAg seroconversion | 24, 48 weeks after drug administration |
Countries
South Korea
Outcome results
None listed