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Trial record 138 of 349 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02805738
First received: June 16, 2016
Last updated: June 19, 2016
Last verified: April 2016
  Purpose
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

Condition Intervention Phase
Chronic Hepatitis B
Drug: CKD-390
Drug: viread
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) [ Time Frame: 24weeks after drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) [ Time Frame: 12, 36, 48 weeks after drug administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The rate of subjects who had normal ALT result [ Time Frame: 12, 24, 36, 48weeks after drug administration ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBeAg loss [ Time Frame: 24, 48 weeks after drug administration ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBeAg seroconversion [ Time Frame: 24, 48 weeks after drug administration ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBsAg loss [ Time Frame: 24, 48 weeks after drug administration ] [ Designated as safety issue: No ]
  • The rate of subjects who showed HBsAg seroconversion [ Time Frame: 24, 48 weeks after drug administration ] [ Designated as safety issue: No ]
  • The rate of subjects who showed Virologic breakthrough [ Time Frame: 12, 24, 36, 48 weeks after drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: April 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Tenofovir disoproxil fumarate 300mg

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).
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02805738

Locations
Korea, Republic of
Korea University Ansan Hospital Not yet recruiting
Ansan, Gyeonggi-do, Korea, Republic of
Contact: Hyengjun Lim, MD    82-31-412-6565    gudwns21@medimail.co.kr   
Bundang Cha Medical Center Not yet recruiting
Bundang, Gyeonggi-do, Korea, Republic of
Contact: Sunggue Hwang, MD    82-31-780-5213    sghwang@cha.ac.kr   
Hanyang University Guri Hospital Recruiting
Guri, Gyeonggi-do, Korea, Republic of
Contact: Joohyun Sohn, MD    82-31-560-2225    sonjh@hanyang.ac.kr   
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Gyeonggi-do, Korea, Republic of
Contact: June Sung Lee, MD    82-31-910-7823    jsleemd@paik.ac.kr   
Gachon University of Medicine and Science Gil Medical Center Active, not recruiting
Incheon, Gyeonggi-do, Korea, Republic of
Ajou University Hospital Active, not recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Busan National University Hospital Active, not recruiting
Busan, Korea, Republic of
Keimyung University Dongsan Medical Center Active, not recruiting
Daegu, Korea, Republic of
Yeungnam University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Heonju Lee, MD    82-53-620-3834    heonjulee@yu.ac.kr   
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Byengseok Lee, MD    82-2-2019-3314    leeks519@yuhs.ac   
Jeju National University Hospital Not yet recruiting
Jeju, Korea, Republic of
Contact: Byungcher Song, MD    82-64-717-1643    drsong@jejunu.ac.kr   
Chungang University Hospital Active, not recruiting
Seoul, Korea, Republic of
Hanyang University Hospital Active, not recruiting
Seoul, Korea, Republic of
Kangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Kwan Sik Lee, MD    82-2-2019-2332    leeks519@yuhs.ac   
Korea University Guro Hosptial Not yet recruiting
Seoul, Korea, Republic of
Contact: Jihoon Kim, MD    82-2-2626-3011    kjhhepar@naver.com   
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of
Seoul Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Active, not recruiting
Seoul, Korea, Republic of
Seoul Saint Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Do Young Kim, MD    82-2-2228-0525    dyk1025@yuhs.ac   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Kwan Sik lee, MD Kangnam severance hospital
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02805738     History of Changes
Other Study ID Numbers: 163HBV15036 
Study First Received: June 16, 2016
Last Updated: June 19, 2016
Health Authority: Korea: Ministry of Food and Drug Safety
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Chong Kun Dang Pharmaceutical:
Chronic Hepatitis B
tenofovir
CKD-390

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on December 02, 2016