EUCTR2020-003570-49-HU进行中（未招募）1 期
Phase III, Open-label, Uncontrolled, Multicenter Study to Assess Efficacy, Pharmacokinetics and Safety of IMMUNORHO in the Prevention of RhD Isoimmunization in Rh(D) negative Women Pregnant with Rh(D) positive Foetuses
Kedrion S.p.A.0 个研究点目标入组 276 人开始时间: 2020年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Subjects who have voluntarily given written Informed Consent and Authorization to Access Personal Health Information after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •2. Age =18 years at the time of screening.
- •3. Rh(D) negative.
- •4. Pregnancy is at 25 (from day 0 to day 7) to 26 (day 7) weeks gestation.
- •5. Negative for anti-D antibodies.
- •6. Carrying a Rh(D) positive (including Dweak and Dpartial ) foetus as determined by antepartum foetal/maternal non-invasive genotyping.
- •7. Individuals who can comply with study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 276
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior administration of RhD immunoglobulin during the current pregnancy.
- •2. History of allergies or severe reactions to immunoglobulins or other blood products.
- •3. Amniocentesis, chorionic villus biopsy, or cordocentesis performed or planned for the current pregnancy.
- •4. Known clinically relevant maternal or foetal abnormality, such as placenta previa for the current pregnancy.
- •5. Intra-operative cell salvage performed or planned for the current pregnancy.
- •6. Blood or blood component transfusion within 6 months of study entry.
- •7. Diagnosis of selective IgA deficiency with anti-IgA antibody.
- •8. Participation in any interventional drug/device clinical trial within 30 days or 5 half-lives whatever is longer prior to Informed Consent.
- •9. Any other medical condition that could interfere with study assessment or interpretation of the data.
- •10. Multiple pregnancy.
- •11. Live attenuated viral vaccine administration within 2-4 weeks before IMMUNORHO or planned within 3 months after the last administration of IMMUNORHO.
- •12. History of malignancy requiring surgery, systemic therapy, or radiation within the prior 5 years or considered not in full remission (except for curatively treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ).
- •13. In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject’s compliance with the protocol requirements, or confound the reliability of the data acquired.
- •14. Be a Kedrion, Parexel, clinical site employee, or their close relative regardless of direct involvement in research activities.
研究者
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