RPCEC00000283尚未招募4 期
Post-licensing study of the therapeutic vaccine HeberNasvac® in patients with chronic hepatitis B virus infection
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 300 人开始时间: 2018年8月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Male or female subjects = 18 years of age.
- •2. Documented chronic hepatitis B determined by HBsAg + for more than 6 months.
- •3. Voluntariness of the patient to participate expressed by delivery of signed informed consent.
排除标准
- •1.Evidence or suspicion of hepatocarcinoma and/or liver cirrhosis by clinical/sonography.
- •2.Clinical, sonographic or serological evidence of decompensated liver disease (gastrointestinal bleeding, hepatic encephalopathy, ascites, spontaneous peritonitis, hepato-renal syndrome, ALT greater than 500 IU / L).
- •3.History of liver transplantation.
- •4.Have received antiviral therapy for chronic hepatitis B (IFN, PEG-IFN, or nucleos(t)ide analogue) in the 6 months prior to inclusion.
- •5.Immunosuppressive therapy in the six months prior to the screening visit.
- •6.History of allergy to any of the ingredients of the vaccine.
- •7.Pregnancy, breast feeding or female subjects who do not use contraceptive methods or who plan a pregnancy that coincides with the course of treatment.
- •8.Presence of mental and / or psychiatric disorders that make it impossible to sign informed consent or patient follow-up.
研究者
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