Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude
NCT ID: NCT02523547
Last Updated: 2015-08-14
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
134 participants
INTERVENTIONAL
2015-01-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cavir
entecavir/0.5mg/day
Cavir
0.5mg/day
Baraclude
entecavir/0.5mg/day
Baraclude
0.5mg/day
Interventions
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Cavir
0.5mg/day
Baraclude
0.5mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
* Patient had documented resistance mutations at any time before or at screening
* Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
* Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
* Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
* Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) \< 50ml/min, Total bilirubin \> 3.0 mg/dl, Albumin \< 2.7 g/dl, Prothrombin time \> INR 2.3
* Patient is pregnant or breastfeeding or willing to be pregnant
* Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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15 Sites
Seoul, , South Korea
Countries
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Central Contacts
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Hanmi Pharmaceutical
Role: CONTACT
Facility Contacts
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Other Identifiers
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HM-CAV-401
Identifier Type: -
Identifier Source: org_study_id
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