NCT01023230已完成1 期
A Phase Ib Dose-Escalation Study to Assess the Safety and Tolerability of DV-601 in Subjects With Chronic Hepatitis B on Concurrent Treatment With a Nucleoside Analogue
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Patient diaries, adverse events, physical exams, and lab tests
研究概览
简要总结
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 to 65 years of age.
- •Signed informed consent.
- •Diagnosis of CHB and candidates for therapy
- •Normal renal function
- •Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.
排除标准
- •Liver disease other than CHB
- •Documented co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), or HIV
- •Previous therapy with interferon alpha.
- •Any other antiviral therapy for chronic hepatitis B within the previous 3 months prior to Screening Visit.
- •Immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of Screening Visit.
- •Evidence of cirrhosis
- •Child-Turcotte-Pugh (CTP) score ≥ 7, either currently or at any occasion in the past
- •Clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
- •Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
- •Participation in any experimental protocol or therapy within 28 days prior to the Screening Visit.
- •Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.
研究组 & 干预措施
DV-601
Experimental
干预措施: DV-601 (Drug)
DV-601
Experimental
干预措施: Entecavir (Drug)
结局指标
主要结局
Patient diaries, adverse events, physical exams, and lab tests
时间窗: Through Day 99
次要结局
- HBV-DNA levels(Change from baseline to Days 43 and 99, and to Weeks 24 and 48)
研究者
研究点 (4)
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