Status and phase
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About
A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus carriers
Full description
Enrollment
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Inclusion criteria
Exclusion criteria
Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
Patient has one or more test results and symptoms at the screening
Patient has one or more test results at the screening
Patient has history of Interferon treatment
Patient is pregnant or breastfeeding or intending to become pregnant during the study
Patient has active microbial, viral, or fungal infections in need of systemic treatment
Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patient
Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
Patient had long term systemic treatment (more than 14 days consecutively) of high dose (over 20 mg of prednisolone or equivalent dose*) corticosteroid (Decision to participate of patient who had local treatment of corticosteroid is allowed in the opinion of the investigator)
*equivalent to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, or betamethasone 2.4 mg
Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient (Benign tumor patient is able to participate in this study at the discretion of the investigator)
Patient has history of organ transplantation
Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
Patient has history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, treatment required ventricular tachyarrhythmias, or unstable angina etc.)
Patient has seizure disorder required anticonvulsants treatment
Uncontrollable diabetic patient (FBS>130mg/dl, HbA1c>7.5%)
Uncontrollable hypertension patient (SBP≥140mmHg 또는 DBP≥90mmHg)
HCV, HDV, or HIV patient
Patient has a plan to participate in other clinical study, or took part in other clinical study within 1 month before enrollment
Patient has hypersensitivity or anaphylactic reaction for components of investigational product or HBV vaccine
Patient has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
Patient has potential to severe febrile or systemic reaction
Subject unacceptable in this study under the opinion of the investigator
Primary purpose
Allocation
Interventional model
Masking
53 participants in 4 patient groups
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Central trial contact
Kyu-Sung Rim, M.D., Ph.D.; Hana Park, M.D.
Data sourced from clinicaltrials.gov
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