CTRI/2021/11/038206已完成4 期
A Prospective, Multi-centre, Phase IV study for Post-Marketing Safety Evaluation of Recombinant Anti-Rho(D) immunoglobulin in the prevention of Maternal Rh-isoimmunization
Bharat Serums and Vaccines Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
- Pms
入排标准
入选标准
- •1. Rh negative female subjects = 18 years of age with negative ICT (nonsensitized).
- •2. Rh negative female subjects who would receive AntiD™ as per approved indications.
- •3. Subjects able to adhere to the study visit schedule and other protocol requirements.
- •4. Subjects willing to participate in the study by giving written informed consent.
排除标准
- •1. Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the trial.
- •2. Subjects participating in another clinical trial in the four weeks before the screening visit.
- •3. History of anaphylactic or other severe systemic reaction to immunoglobulins.
- •4. Subjects requiring blood transfusion.
研究者
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