NCT02693652已完成1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
研究概览
简要总结
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
详细描述
- Objectives: To explore the appropriate dose of a therapeutic hepatitis B vaccine through the evaluation of safety, tolerability, and efficacy
- Subjects: Chronic hepatitis B carrier with normal ALT range
- Study hypothesis: The immune tolerance break and strong immune responses in the chronic hepatitis B carrier could be achieved with therapeutic hepatitis B vaccine containing novel adjuvant
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between 19 to 60 years of age
- •Chronic hepatitis B carriers (HBsAg positive over 6 months)
- •HBeAg positive patient, or patient who had lost HBeAg during Antiviral drug treatment
- •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)
- •Patient has low ALT than 1.1 fold of upper limit of normal ALT level at screening
- •Patient is able to provide written informed consent by oneself or legal representative
排除标准
- •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
- •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)
- •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
- •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
结局指标
主要结局
Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
时间窗: 7 days after each vaccination
Occurrence of severe local and/or systemic tolerability signs and symptoms measured for 7 days after each vaccination
次要结局
- HBeAg loss(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
- HBe seroconversion rate(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
- HBsAg loss(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
- HBsAg seroconversion rate(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
- HBV DNA level(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
- HBV specific T cell immunity(at the 3rd month (for 3 shot group) or 6th month (for 6 shot group))
研究者
研究点 (2)
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