Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
NCT ID: NCT02588937
Last Updated: 2016-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
76 participants
INTERVENTIONAL
2015-10-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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EntecaBell ODT.
EntecaBell ODT. 0.5mg
Baraclude Tab.
Baraclude Tab. 0.5mg
Interventions
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EntecaBell ODT. 0.5mg
Baraclude Tab. 0.5mg
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Dankook University Hospital
Cheonan, Chungcheongnam-do, South Korea
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
Kyungpook National University Hospital
Daegu, Gyeong Sangbuk-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Jeju National University Hospital
Jeju City, Jeju-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chonnam National University Hospital
Gwangju, Jeollanam-do, South Korea
Konkuk University Chungju Hospital
Chungju, North Chungcheong, South Korea
Countries
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Other Identifiers
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361HBV15017
Identifier Type: -
Identifier Source: org_study_id