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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805738
Recruitment Status : Unknown
Verified April 2016 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 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




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

Secondary Outcome Measures :
  1. The rate of subjects who showed HBV DNA undetected (less than 20IU/mL) [ Time Frame: 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 [ Time Frame: 12, 24, 36, 48 weeks after drug administration ]
  3. The rate of subjects who had normal ALT result [ Time Frame: 12, 24, 36, 48weeks after drug administration ]
  4. The rate of subjects who showed HBeAg loss [ Time Frame: 24, 48 weeks after drug administration ]
  5. The rate of subjects who showed HBeAg seroconversion [ Time Frame: 24, 48 weeks after drug administration ]
  6. The rate of subjects who showed HBsAg loss [ Time Frame: 24, 48 weeks after drug administration ]
  7. The rate of subjects who showed HBsAg seroconversion [ Time Frame: 24, 48 weeks after drug administration ]
  8. The rate of subjects who showed Virologic breakthrough [ Time Frame: 12, 24, 36, 48 weeks after drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805738


Locations
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Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Kwan Sik lee, MD Kangnam severance hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02805738    
Other Study ID Numbers: 163HBV15036
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Chronic Hepatitis B
tenofovir
CKD-390
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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