KCT0001249已完成未知
A multi-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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •(1) Adult between 19 to 60 years of age
- •(2) Chronic hepatitis B carriers (HBsAg positive over 6 months)
- •(3) HBeAg positive patient, or patient who had lost HBeAg during Antiviral drug treatment
- •(4) Antiviral drug treated patient reducing the HBV DNA level below 2000 IU/mL measured by COBAS TaqManM HBV Test (Duration of drug administration should be over 6 months and no limitation on the type of antiviral drug)
- •(5) Patient has low ALT than 1.1 fold of upper limit of normal ALT level at screening
- •(6) Patient is able to provide written informed consent by oneself or legal representative
排除标准
- •(1)Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
- •(2) Patient has one or more test results and symptoms at the screening
- •- ALT > upper limit of normal level X 1.1
- •- Total bilirubin > upper limit of normal
- •- Prothrombin time > Over 3 second than normal
- •- Serum Albumin < 30 g/L (3 g/dL)
- •- Patient has history of ascites, yellow jaundice, variceal hemorrhage, hepatic encephalopathy, or liver failure
- •- Liver FibroScan > F3
- •(F0: no fibrosis, F1: portal fibrosis, F2: periportal fibrosis, F3: septal fibrosis, F4: cirrhosis)
- •(3) Patient has one or more test results at the screening
- •- Hemoglobin < 9.0 g/dL
- •- Absolute neutrophil count (ANC) < 1.5 x 109 /L (1500 /mm3)
- •- Platelet count < 100 x 109 /L (100 x 103 /mm3)
- •- Serum creatinine > 1.5 mg/dL
- •- Serum amylase > 2 x ULN and Lipase > 2 x ULN
- •(4) Patient has history of Interferon treatment
- •(5) Patient is pregnant or breastfeeding or intending to become pregnant during the study
- •(6) Patient has active microbial, viral, or fungal infections in need of systemic treatment
- •(7) Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patient
- •(8) Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
- •(9) 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
- •(10) 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)
- •(11) Patient has history of organ transplantation
- •(12) Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
- •(13) 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.)
- •(14) Patient has seizure disorder required anticonvulsants treatment
- •(15) Uncontrollable diabetic patient (FBS>130mg/dl, HbA1c>7.5%)
- •(16) Uncontrollable hypertension patient (SBP=140mmHg ?? DBP=90mmHg)
- •(17) HCV, HDV, or HIV patient
- •(18) Patient has a plan to participate in other clinical study, or took part in other clinical study within 1 month before enrollment
- •(19) Patient has hypersensitivity or anaphylactic reaction for components of investigational product or HBV vaccine
- •(20) Patient has continuous drinking (>21 units/week, 1 unit = 10g of pure alcohol) or dependence on alcohol
- •(21) Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
- •(22) Patient has potential to severe febrile or systemic reaction
- •(23) Subject unacceptable in this study under the opinion of the investigator
研究者
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