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

Last updated: June 19, 2016
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Trial Status Unknown

Phase

3

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02805738
163HBV15036
  • Ages > 19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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, decidedto join the clinical trials by their will and signed inform consent

Exclusion

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 immunodeficiencyvirus (HIV)

  3. Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhageor 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

  1. Patients who are estimated to have hepatocellular carcinoma (HCC) through imagingexamination or showed alpha-fetoprotein(AFP) more than 50ng/mL

  2. Patients who show Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gaultequation

  3. Patients with disease like heart failure, renal failure, pancreatitis thatinvestigators consider ineligible for this study

  4. Patients who have other hepatic diseases like hematochromatosis, Wilson's disease,alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome

  5. Patients with genetic disease like Galactose intolerance, lapplactase deficiency,Glucose-galactose malabsorption

  6. History of malignant tumor within 5 years

  7. Patients who take any other investigational product within 30 days

  8. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxicdrugs for period of Clinical Trial

  9. Pregnant, breast-feeding and childbearing age who don't use adequate contraception

  10. Patients who receive an organ transplant or bone marrow transplant or are going toreceived surgury

  11. History of allergic reaction to the investigational product

  12. Patients that investigators consider ineligible for this study

Study Design

Total Participants: 158
Study Start date:
April 01, 2016
Estimated Completion Date:
March 31, 2018

Study 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).

Connect with a study center

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Bundang Cha Medical Center

    Bundang, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital

    Guri, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Gachon University of Medicine and Science Gil Medical Center

    Incheon, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Busan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Jeju National University Hospital

    Jeju,
    Korea, Republic of

    Site Not Available

  • Chungang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hanyang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hosptial

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Saint Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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