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

June 19, 2016 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Active, not recruiting
        • Busan National University Hospital
      • Daegu, Korea, Republic of
        • Active, not recruiting
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Not yet recruiting
        • Yeungnam University Medical Center
        • Contact:
      • Daejeon, Korea, Republic of
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
      • Jeju, Korea, Republic of
        • Not yet recruiting
        • Jeju National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Chungang University Hospital
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Hanyang University Hospital
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Kangnam Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Korea University Guro Hosptial
        • Contact:
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Seoul ASAN Medical Center
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Seoul Saint Mary's Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
      • Bundang, Gyeonggi-do, Korea, Republic of
        • Not yet recruiting
        • Bundang CHA Medical Center
        • Contact:
      • Guri, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Hanyang University Guri Hospital
        • Contact:
      • Ilsan, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
      • Incheon, Gyeonggi-do, Korea, Republic of
        • Active, not recruiting
        • Gachon University of Medicine and Science Gil Medical Center
      • Suwon, Gyeonggi-do, Korea, Republic of
        • Active, not recruiting
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time Frame: 24weeks after drug administration
24weeks after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)
Time Frame: 12, 36, 48 weeks after drug administration
12, 36, 48 weeks after drug administration
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
12, 24, 36, 48 weeks after drug administration
The rate of subjects who had normal ALT result
Time Frame: 12, 24, 36, 48weeks after drug administration
12, 24, 36, 48weeks after drug administration
The rate of subjects who showed HBeAg loss
Time Frame: 24, 48 weeks after drug administration
24, 48 weeks after drug administration
The rate of subjects who showed HBeAg seroconversion
Time Frame: 24, 48 weeks after drug administration
24, 48 weeks after drug administration
The rate of subjects who showed HBsAg loss
Time Frame: 24, 48 weeks after drug administration
24, 48 weeks after drug administration
The rate of subjects who showed HBsAg seroconversion
Time Frame: 24, 48 weeks after drug administration
24, 48 weeks after drug administration
The rate of subjects who showed Virologic breakthrough
Time Frame: 12, 24, 36, 48 weeks after drug administration
12, 24, 36, 48 weeks after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kwan Sik lee, MD, Kangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 163HBV15036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings