Evaluation of the vaccine candidate CIGB-230 in individuals with chronic renal insufficiency for the prevention of hepatitis C virus infection. Phase I/II clinical trial, controlled, randomized, blinded, adaptive.

Centro de Ingeniería Genética y Biotecnología (CIGB).0 个研究点目标入组 60 人开始时间: 2010年9月27日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Prevention

•Adults of both genders Age between 18 and 60 years Chronic renal insufficiency (CRI) in stage IV (criteria for posterior hemodialysis treatment) with glomerular filtrate between 24 and 15. Informed consent signed.

•Positive to anti-HCV. Positive to HCV RNA. Diagnosis of Lupus erithematosus or other documented collagen diseases Positive to HIV Positive to HBV Concomitant infection with HAV Women in fertile age that use hormone-based contraceptive methods. Women and men in reproductive age without contraceptive control. Pregnancy and breastfeeding. Body mass index under 16 Patients with previous diagnosis of sicklemia or hemophilia. Previous diagnosis of mental or psychiatric diseases. Patients with background of severe allergy (asthma degree III or IV). Consumption of immunosuppresive/ immunomodulators drugs at the inclusion or in the three months previous to the study. Fever above >37.8°C, in the moment or 24 hours previous to the administration of the vaccine, or acute infectious disease not related to HCV infection suggested by clinical evaluation. Temporary exclusion criterium. Previous diagnosis of active cancer.

发起方

Centro de Ingeniería Genética y Biotecnología (CIGB).