A Prospective, Randomized, Open Label, Phase III, Multicentric ClinicalTrial To Compare The Efficacy And Safety Of Monoclonal Anti Rho (D)Immunoglobulin With Polyclonal Anti Rho (D) Immunoglobulin InPrevention of Hemolytic Disease Of Newborn.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- No sensitization (negative indirect coomb’s test result)
研究概览
简要总结
This was a prospective, randomized, open-label, phase III, multicentric study to assess prevention of Rh(D) immunization in Rh-negative women giving birth to Rh positive baby by administration of either the Test or Reference drug. The primary efficacy parameter in the study was absence of Rh(D) immunization (negative indirect Coombs test) at the end of the study206 patients (101 in Reference vs 105 in Test group) enrolled in this study did not demonstrate difference at baseline parameters.
On day 180, 1 subject randomized to Rhogam® (Reference) versus none randomised to Rhoclone® (Test) group showed Positive ICT.
On day 180, negative ICT was reported in 89.5% in the Rhoclone® (Test) group and 86.1% in the Rhogam® (Reference) group with a p-value of 0.30
5 Treatment-Emergent Adverse Events (TEAEs) were reported – 3 in Test versus 2 in Reference group. All TEAEs were unrelated to treatment administered.
Immunogenicity testing: No subject receiving Rhoclone® (Test) developed antibodies to Rhoclone® post administration of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Rh negative pregnant non-sensitised (negative indirect Coombs titre) women delivering live Rh positive infant.
- •Patients able to adhere to the study visit schedule and other protocol requirements
- •Subjects willing to participate in the study by giving written informed consent and permission to record the same on a video camera.
排除标准
- •Rh negative women with husbands who are Rh negative.
- •Rh D positive or Rh D negative sensitised (positive indirect coombs titre) pregnant women with antibodies to Rh antigen.
- •Rh D negative women delivering Rh D negative infants.
- •Women with history of receiving incompatible blood transfusion.
- •Premature delivery prior to 36 weeks.
- •Women delivering stillborn baby.
- •Patients suffering from any medical condition that in the investigators opinion could compromise the patients ability to participate in the trial.
- •Women participating in another clinical trial in the four weeks before the screening visit.
- •History of anaphylactic or other severe systemic reaction to immunoglobulins.
- •Women with known history of IgA deficiency.
- •Women requiring blood transfusion after delivery.
- •(If already randomized, such patients will be withdrawn from the study)
- •Women with Abruptio placentae, Placenta previa or IUD will be excluded.
结局指标
主要结局
No sensitization (negative indirect coomb’s test result)
时间窗: 72 hours, day 90 and day 180 post study drug administration
次要结局
- Safety assessment(at screening, post study drug administration at 72 hours, day 90 and day 180)
- Absence of antibodies against Monoclonal Rho Anti-D(at screening , post Monoclonal Rho Anti-D administration on day 90 and day 180)