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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02805738
• Other study ID #: 163HBV15036
• Status: Recruiting
• Phase: Phase 3
• First received: June 16, 2016
• Last updated: June 19, 2016
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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, a-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• CKD-390
CKD-390 1 Tablet (48 weeks)
• viread
viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-do
Korea, Republic of	Bundang Cha Medical Center	Bundang	Gyeonggi-do
Korea, Republic of	Busan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi-do
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan	Gyeonggi-do
Korea, Republic of	Gachon University of Medicine and Science Gil Medical Center	Incheon	Gyeonggi-do
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Kangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Guro Hosptial	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)		24weeks after drug administration	No
Secondary	The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)		12, 36, 48 weeks after drug administration	No
Secondary	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	No
Secondary	The rate of subjects who had normal ALT result		12, 24, 36, 48weeks after drug administration	No
Secondary	The rate of subjects who showed HBeAg loss		24, 48 weeks after drug administration	No
Secondary	The rate of subjects who showed HBeAg seroconversion		24, 48 weeks after drug administration	No
Secondary	The rate of subjects who showed HBsAg loss		24, 48 weeks after drug administration	No
Secondary	The rate of subjects who showed HBsAg seroconversion		24, 48 weeks after drug administration	No
Secondary	The rate of subjects who showed Virologic breakthrough		12, 24, 36, 48 weeks after drug administration	No