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

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-390
viread
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B, tenofovir, CKD-390

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Bundang Cha Medical Center
  • Hanyang University Guri HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Gachon University of Medicine and Science Gil Medical Center
  • Ajou University Hospital
  • Busan National University Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medical Center
  • Chungnam National University Hospital
  • Jeju National University Hospital
  • Chungang University Hospital
  • Hanyang University Hospital
  • Kangnam Severance Hospital
  • Korea University Guro Hosptial
  • Samsung Medical Center
  • Seoul Asan Medical Center
  • Seoul National University Hospital
  • Seoul Saint Mary's Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Active comparator Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)

Secondary Outcome Measures

The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
The rate of subjects who had normal ALT result
The rate of subjects who showed HBeAg loss
The rate of subjects who showed HBeAg seroconversion
The rate of subjects who showed HBsAg loss
The rate of subjects who showed HBsAg seroconversion
The rate of subjects who showed Virologic breakthrough

Full Information

First Posted
June 16, 2016
Last Updated
June 19, 2016
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02805738
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic Hepatitis B, tenofovir, CKD-390

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Active comparator Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CKD-390
Other Intervention Name(s)
Tenofovir disoproxil aspartate 308.04mg
Intervention Description
CKD-390 1 Tablet (48 weeks)
Intervention Type
Drug
Intervention Name(s)
viread
Other Intervention Name(s)
Tenofovir disoproxil fumarate 300mg
Intervention Description
viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)
Primary Outcome Measure Information:
Title
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time Frame
24weeks after drug administration
Secondary Outcome Measure Information:
Title
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time Frame
12, 36, 48 weeks after drug administration
Title
The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level
Time Frame
12, 24, 36, 48 weeks after drug administration
Title
The rate of subjects who had normal ALT result
Time Frame
12, 24, 36, 48weeks after drug administration
Title
The rate of subjects who showed HBeAg loss
Time Frame
24, 48 weeks after drug administration
Title
The rate of subjects who showed HBeAg seroconversion
Time Frame
24, 48 weeks after drug administration
Title
The rate of subjects who showed HBsAg loss
Time Frame
24, 48 weeks after drug administration
Title
The rate of subjects who showed HBsAg seroconversion
Time Frame
24, 48 weeks after drug administration
Title
The rate of subjects who showed Virologic breakthrough
Time Frame
12, 24, 36, 48 weeks after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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, α-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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan Sik lee, MD
Organizational Affiliation
Kangnam severance hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyengjun Lim, MD
Phone
82-31-412-6565
Email
gudwns21@medimail.co.kr
Facility Name
Bundang Cha Medical Center
City
Bundang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunggue Hwang, MD
Phone
82-31-780-5213
Email
sghwang@cha.ac.kr
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joohyun Sohn, MD
Phone
82-31-560-2225
Email
sonjh@hanyang.ac.kr
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June Sung Lee, MD
Phone
82-31-910-7823
Email
jsleemd@paik.ac.kr
Facility Name
Gachon University of Medicine and Science Gil Medical Center
City
Incheon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Busan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heonju Lee, MD
Phone
82-53-620-3834
Email
heonjulee@yu.ac.kr
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byengseok Lee, MD
Phone
82-2-2019-3314
Email
leeks519@yuhs.ac
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byungcher Song, MD
Phone
82-64-717-1643
Email
drsong@jejunu.ac.kr
Facility Name
Chungang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwan Sik Lee, MD
Phone
82-2-2019-2332
Email
leeks519@yuhs.ac
Facility Name
Korea University Guro Hosptial
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihoon Kim, MD
Phone
82-2-2626-3011
Email
kjhhepar@naver.com
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Young Kim, MD
Phone
82-2-2228-0525
Email
dyk1025@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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

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