Clinical trial NCT02805738: Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B
tenofovir
CKD-390
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
timeFrame: 24weeks after drug administration
Secondary outcomes:
measure: The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
timeFrame: 12, 36, 48 weeks after drug administration
measure: The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
timeFrame: 12, 24, 36, 48 weeks after drug administration
measure: The rate of subjects who had normal ALT result
timeFrame: 12, 24, 36, 48weeks after drug administration
measure: The rate of subjects who showed HBeAg loss
timeFrame: 24, 48 weeks after drug administration
measure: The rate of subjects who showed HBeAg seroconversion
timeFrame: 24, 48 weeks after drug administration
measure: The rate of subjects who showed HBsAg loss
timeFrame: 24, 48 weeks after drug administration
measure: The rate of subjects who showed HBsAg seroconversion
timeFrame: 24, 48 weeks after drug administration
measure: The rate of subjects who showed Virologic breakthrough
timeFrame: 12, 24, 36, 48 weeks after drug administration
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Bundang
country: Korea, Republic of
facility: Bundang Cha Medical Center
state: Gyeonggi-do
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University of Medicine and Science Gil Medical Center
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Busan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chungang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hosptial
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Kangnam severance hospital
name: Kwan Sik lee, MD
role: PRINCIPAL_INVESTIGATOR
References: