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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02805738
• Collaborator: (none)
• Enrollment: 158
• Locations: 20
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 7.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: CKD-390; Drug: viread	Phase 3

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2017
• Anticipated Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group 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	Drug: CKD-390; CKD-390 1 Tablet (48 weeks); Other Names: Tenofovir disoproxil aspartate 308.04mg
Active Comparator: Active comparator Group 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	Drug: viread; viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks); Other Names: Tenofovir disoproxil fumarate 300mg

Outcome Measures

Primary Outcome Measures

1. The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) [24weeks after drug administration]

Secondary Outcome Measures

1. The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) [12, 36, 48 weeks after drug administration]

2. 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]

3. The rate of subjects who had normal ALT result [12, 24, 36, 48weeks after drug administration]

4. The rate of subjects who showed HBeAg loss [24, 48 weeks after drug administration]

5. The rate of subjects who showed HBeAg seroconversion [24, 48 weeks after drug administration]

6. The rate of subjects who showed HBsAg loss [24, 48 weeks after drug administration]

7. The rate of subjects who showed HBsAg seroconversion [24, 48 weeks after drug administration]

8. The rate of subjects who showed Virologic breakthrough [12, 24, 36, 48 weeks after drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

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

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

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

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

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

6. History of malignant tumor within 5 years

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

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

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

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

11. History of allergic reaction to the investigational product

12. Patients that investigators consider ineligible for this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Ansan Hospital	Ansan	Gyeonggi-do	Korea, Republic of
2	Bundang Cha Medical Center	Bundang	Gyeonggi-do	Korea, Republic of
3	Hanyang University Guri Hospital	Guri	Gyeonggi-do	Korea, Republic of
4	Inje University Ilsan Paik Hospital	Ilsan	Gyeonggi-do	Korea, Republic of
5	Gachon University of Medicine and Science Gil Medical Center	Incheon	Gyeonggi-do	Korea, Republic of
6	Ajou University Hospital	Suwon	Gyeonggi-do	Korea, Republic of
7	Busan National University Hospital	Busan		Korea, Republic of
8	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
9	Yeungnam University Medical Center	Daegu		Korea, Republic of
10	Chungnam National University Hospital	Daejeon		Korea, Republic of
11	Jeju National University Hospital	Jeju		Korea, Republic of
12	Chungang University Hospital	Seoul		Korea, Republic of
13	Hanyang University Hospital	Seoul		Korea, Republic of
14	Kangnam Severance Hospital	Seoul		Korea, Republic of
15	Korea University Guro Hosptial	Seoul		Korea, Republic of
16	Samsung Medical Center	Seoul		Korea, Republic of
17	Seoul Asan Medical Center	Seoul		Korea, Republic of
18	Seoul National University Hospital	Seoul		Korea, Republic of
19	Seoul Saint Mary's Hospital	Seoul		Korea, Republic of
20	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Kwan Sik lee, MD, Kangnam severance hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT02805738
• Other Study ID Numbers: 163HBV15036
• First Posted: Jun 20, 2016
• Last Update Posted: Jun 21, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Chong Kun Dang Pharmaceutical: Chronic Hepatitis B; tenofovir; CKD-390
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Tenofovir

Study Results

No Results Posted as of Jun 21, 2016