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

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: Unknown
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: CKD-390; Drug: viread

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: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 3

Contacts and Locations

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: Heonju Lee, MD; Phone Number: 82-53-620-3834; Email: heonjulee@yu.ac.kr
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • Chungnam National University Hospital
    • Contact: Byengseok Lee, MD; Phone Number: 82-2-2019-3314; Email: leeks519@yuhs.ac
  • Jeju, Korea, Republic of
    • Not yet recruiting
    • Jeju National University Hospital
    • Contact: Byungcher Song, MD; Phone Number: 82-64-717-1643; Email: drsong@jejunu.ac.kr
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Severance Hospital
    • Contact: Do Young Kim, MD; Phone Number: 82-2-2228-0525; Email: dyk1025@yuhs.ac
  • 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: Kwan Sik Lee, MD; Phone Number: 82-2-2019-2332; Email: leeks519@yuhs.ac
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Korea University Guro Hosptial
    • Contact: Jihoon Kim, MD; Phone Number: 82-2-2626-3011; Email: kjhhepar@naver.com
  • 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: Hyengjun Lim, MD; Phone Number: 82-31-412-6565; Email: gudwns21@medimail.co.kr
    • Bundang, Gyeonggi-do, Korea, Republic of
      • Not yet recruiting
      • Bundang Cha Medical Center
      • Contact: Sunggue Hwang, MD; Phone Number: 82-31-780-5213; Email: sghwang@cha.ac.kr
    • Guri, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Hanyang University Guri Hospital
      • Contact: Joohyun Sohn, MD; Phone Number: 82-31-560-2225; Email: sonjh@hanyang.ac.kr
    • Ilsan, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Inje University Ilsan Paik Hospital
      • Contact: June Sung Lee, MD; Phone Number: 82-31-910-7823; Email: jsleemd@paik.ac.kr
    • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)	24weeks after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)	12, 36, 48 weeks after drug administration
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
The rate of subjects who had normal ALT result	12, 24, 36, 48weeks after drug administration
The rate of subjects who showed HBeAg loss	24, 48 weeks after drug administration
The rate of subjects who showed HBeAg seroconversion	24, 48 weeks after drug administration
The rate of subjects who showed HBsAg loss	24, 48 weeks after drug administration
The rate of subjects who showed HBsAg seroconversion	24, 48 weeks after drug administration
The rate of subjects who showed Virologic breakthrough	12, 24, 36, 48 weeks after drug administration

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Kwan Sik lee, MD, Kangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: tenofovir; Chronic Hepatitis B; CKD-390
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: 163HBV15036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No