RPCEC00000110已完成1 期
Safety, Tolerance and preliminary Efficacy of nasal administration of NASVAC therapeutic vaccine candidate in chronic hepatitis B patients- A phase I, open, not controlled clinical trial”.
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.0 个研究点目标入组 20 人开始时间: 2011年5月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •1) Adults from 18 to 65 years old, both sexes. 2) HBsAg seropositivity longer than six months. 3) Serum ALT levels over the upper normal limit detected (at least one time) during the six month period prior to study enrollment. 4) Previous treatment with alpha 2b interferon or with hepatitis specific antivirals that failed to control viral infection. Patients considered intolerant to standard treatment due to medical criteria or adverse reactions to this kind of therapy are also allowed to enter the study. 5) Six month washout period of the last treatment with interferon or other antivirals. 6) Inform Consent Act signed by the subject.
排除标准
- •1) History of acute or chronic diseases of respiratory airways. 2) Seropositivity for markers of Hepatitis C virus infection (HCV). 3) Seropositivity for markers of Human Immunodeficiency Virus infection (HIV1, 2). 4) Women in reproductive age without a birth control method or using a hormonal contraceptive. 5) Pregnancy, puerperium or breastfeeding. 6) Uncontrolled chronic diseases (eg., high blood pressure, diabetes mellitus, renal failure, heart failure, malignant neoplasia, hyperthyroidism, autoimmune diseases, epilepsy, severe mental depression, etc). 7) Treatment with Interferon or any other HBV specific systemic antiviral agent (eg. Lamivudine) in the 6 month prior to study enrollment. 8) History of concomitant liver diseases of any aethiology, ie. Alcoholism, autoimmune hepatitis, toxic hepatitis, Wilson´s Disease, Haemochromatosis. 9) History of liver transplantation, cirrhosis, or primary liver hepatocacinoma (diagnosis made by clinic or ultrasonography). 10) ALT or AST values over 500 U/L detected at any moment during the study. 11) Fever higher than 37.8ºC during or 24 hours prior to nasal administration of the vaccine candidate or acute infectious disease suspected by clinical examination. 12) History of receiving another experimental product or hepatitis B vaccine in the six months prior to study enrollment. 13) Haemoglobin levels below 9g/L, platelet levels below 50x109 /L, Global leukocyte count > 12x109 cells/L or below 3 x109 cells/L. 14) Underlying immunosuppressive disease or immunosuppressive/immunostimulantory drugs intake (including steroids) in the six month prior to study entry. 15) History of severe allergy that need continued treatment with steroids (Grade III or IV Asthma, urtycaria, Dermatitis, Bronchitis, etc). 16) Obvious mental incapacity to give written consent or to allow follow up of the patient.
研究者
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