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Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT02588937
Recruitment Status : Unknown
Verified October 2015 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: EntecaBell ODT. 0.5mg Drug: Baraclude Tab. 0.5mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Experimental: EntecaBell ODT. Drug: EntecaBell ODT. 0.5mg
Active Comparator: Baraclude Tab. Drug: Baraclude Tab. 0.5mg



Primary Outcome Measures :
  1. The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) [ Time Frame: 48 week ]

Secondary Outcome Measures :
  1. The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) [ Time Frame: 24 week ]
  2. The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10) [ Time Frame: 24, 48 week ]
  3. The rate of subjects who showed HBeAg serum loss [ Time Frame: 24, 48 week ]
  4. The rate of subjects who showed HBeAg seroconversion [ Time Frame: 24, 48 week ]
  5. The rate of subjects who showed HBsAg serum loss [ Time Frame: 48 week ]
  6. The rate of subjects who showed HBsAg seroconversion [ Time Frame: 48 week ]
  7. The rate of subjects who showed Virologic breakthrough [ Time Frame: 12, 24, 48 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over the age of 20 years old
  2. Patients with Chronic Hepatitis B diagnosed
  3. Patients who show positive HBsAg
  4. Patients who show positive HBeAg or negative HBeAg
  5. Patients who showed HBV DNA undetected(less than 300 copies/mL)
  6. Patients who have administered Baraclude Tab. 0.5mg for 1~4 years
  7. Patients who showed ALT less than 5 times of the upper limit in the normal range
  8. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

  1. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
  2. Patients with a uncompensated liver disease who have at least one of the following values or signs

    • Total bilirubin > 2.5mg/dl
    • Prothrombin time delayed more than three seconds of upper limit in the normal range
    • Serum Albumin < 3 g/dL
    • A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss
  3. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
  4. Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
  5. Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
  6. Administration of other Investigational Product within 30 days
  7. History of malignant tumor within 5 years (including leukemia and lymphoma)
  8. Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial
  9. Patients who have other hepatic diseases except hepatitis B
  10. Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks
  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 are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial
  14. Patients who received an organ transplant or are going to received an organ transplant
  15. Severe hypersensitivity to Entecavir
  16. Another clinical condition in investigator's judgement

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): NCT02588937


Locations
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Korea, Republic of
Konkuk University Chungju Hospital
Chungju, Chungcheongbuk-do, Korea, Republic of
Dankook University Hospital
Cheonan, ChungCheongnam-do, Korea, Republic of
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, Korea, Republic of
Kyungpook National University Hospital
Daegu, Gyeong sangbuk-do, Korea, Republic of
Hanyang University Guri Hospital
Guri, Gyeonggi-do, Korea, Republic of
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, Korea, Republic of
Jeju National University Hospital
Jeju, Jeju-do, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of
Chonnam National University Hospital
Gwangju, Jeollanam-do, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02588937     History of Changes
Other Study ID Numbers: 361HBV15017
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: October 2015
Keywords provided by Chong Kun Dang Pharmaceutical:
Entecavir, EntecaBell ODT., Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Entecavir
Antiviral Agents
Anti-Infective Agents