Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 347
- 试验地点
- 10
- 主要终点
- Negative result for coombs test up to six months after immunization
研究概览
简要总结
This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).
详细描述
This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until six months to verification of negative Coombs maintenance. Safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Agree to participate, sign and date ICF;
- •18 years old or older;
- •Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby.
排除标准
- •Be participating simultaneously or have participated in another clinical trial within the last 12 months;
- •Mothers who are allergic to any components of the formula;
- •Mothers who have a history of IgA deficiency or IgA antibody present;
- •Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis;
- •Mothers who have indirect Coombs test positive at the beginning of the treatment;
- •Rh-negative mothers whose delivered Rh-negative babies;
- •Abnormalities of the coagulation system;
- •Patients who made use of vaccines made with live pathogens in the last 03 months or will make during the study;
- •Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;
- •Principal Investigator of the study criteria.
结局指标
主要结局
Negative result for coombs test up to six months after immunization
时间窗: up to six months
Will be evaluated by proportion of participants that presented negative result for coombs test until six months after passive immunization with investigational product.
次要结局
- Adverse Events Report(up to six months)