Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet
- Registration Number
- NCT02805738
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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 Vireadยฎ 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 158
- 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
-
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, ฮฑ-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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active comparator Group viread 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 Experimental Group CKD-390 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
- Primary Outcome Measures
Name Time Method The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) 24weeks after drug administration
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (20)
Korea University Ansan Hospital
๐ฐ๐ทAnsan, Gyeonggi-do, Korea, Republic of
Bundang Cha Medical Center
๐ฐ๐ทBundang, Gyeonggi-do, Korea, Republic of
Jeju National University Hospital
๐ฐ๐ทJeju, Korea, Republic of
Yeungnam University Medical Center
๐ฐ๐ทDaegu, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Gachon University of Medicine and Science Gil Medical Center
๐ฐ๐ทIncheon, Gyeonggi-do, Korea, Republic of
Severance Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Hanyang University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Korea University Guro Hosptial
๐ฐ๐ทSeoul, Korea, Republic of
Kangnam Severance Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Keimyung University Dongsan Medical Center
๐ฐ๐ทDaegu, Korea, Republic of
Inje University Ilsan Paik Hospital
๐ฐ๐ทIlsan, Gyeonggi-do, Korea, Republic of
Seoul Saint Mary's Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Hanyang University Guri Hospital
๐ฐ๐ทGuri, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
๐ฐ๐ทSuwon, Gyeonggi-do, Korea, Republic of
Chungang University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Busan National University Hospital
๐ฐ๐ทBusan, Korea, Republic of
Chungnam National University Hospital
๐ฐ๐ทDaejeon, Korea, Republic of
Seoul Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of