KCT0001395招募中未知
A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 150
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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1)age between 20 and 75 year-old
- •2)HBsAg-positive for > 6 months apart (medical history can be alternative)
- •3)currently being treated with entecavir 0.5 mg/day for more than 18 months
- •4)undetectable HBV DNA in serum and HBeAg-negative or positive for > 1year
- •5)HBsAg titer < 3,000 IU/mL
- •6)ALT < 300 IU/L
- •7)Signed written informed consent after being instructed about the objective and procedure of the clinical study
排除标准
- •1)Patients with decompensated liver cirrhosis, any one of the following
- •?serum bilirubin > 3 mg/dL
- •?prothrombin time > 6 seconds prolonged or INR >2.3
- •?serum albumin < 2.8 g/dL
- •?History of ascites, variceal hemorrhage, or hepatic encephalopathy
- •?Child-Pugh score =7 (Child-Pugh class B or C)
- •2)Patients who have evidence of renal insufficiency defined as serum creatinine>1.5 mg/dL
- •3)Patients with psychological problem including depression
- •4)Patients who have previous/current significant co-morbidities including congestive heart failure, chronic kidney disease, hematologic disease and malignancy including hepatocellular carcinoma(patients with malignancy cured 5 years before screening can be enrolled)
- •5)Patients with seropositivity for anti-HCV, anti-HDV or anti-HIV
- •6)Patients who have excessive alcohol consumption (> 30 g/day)
- •7)Patients who have evidence of autoimmune hepatitis, hemochromatosis or Wilson’s disease
- •8)Pregnant or breast feeding females or plan for pregnancy or no contraception
- •9)Patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
- •10)Patients who have an psoriasis
- •11)Patients who have history of antiviral-resistant HBV after previous treatment with oral antiviral agents
- •12)Previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation Recipients
- •13)Patients who have a history of hypersensitivity to study drug
- •14)uncontrollable seizure, convulsion and/or central nervous system disorders
- •15)Patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
- •16)neutrophil count < 1,500/mm3 or platelet count < 75,000/mm3 or hemoglobin < 10 g/dl
- •17)Patients with Pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator’s discretion)
- •18)Patients who have a fever = 38 °C at the baseline
- •19)Patients who have a risk of febrile response or systemic reaction
- •20)Patients who the investigator deems inappropriate to participate in this study
研究者
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