ISRCTN12057804进行中（未招募）3 期
A phase 3 randomized, placebo-controlled, double-blind, multicenter study to evaluate the efficacy and safety of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pregnant and an estimated gestational age (GA) (based on ultrasound dating) from Week 13 and 0/7 days to Week 16 and 6/7 days at randomization
- •2. History of severe Hemolytic Disease of the Fetus and Newborn (HDFN) in a prior pregnancy defined as:
- •2.1. documented fetal anemia, or received greater than or equal to (>=)1 IUT as a result of HDFN or
- •2.2. fetal loss or neonatal death as a result of HDFN, with maternal alloantibody titers for Rhesus antigen D protein (RhD), Kell, Kell Rhesus antigen C protein (Rhc), Rhesus antigen E protein (RhE), or RhC antigen above the critical levels (anti-Kell >=4; other >=16) and evidence of an antigen-positive fetus
- •3. During the current pregnancy, presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level (anti-Kell >= 4; other >=16) based on the designated central lab results at screening
- •4. Evidence of antigen-positivity corresponding to the current maternal alloantibody (RhD, Kell, Rhc, RhE, or RhC) confirmed by non-invasive antigen cell-free fetal DNA (cffDNA) performed at the central laboratory.
- •5. Have screening laboratory values within the study protocol-specified parameters:
- •5.1. albumin, >=2.6 grams (g) per deciliter (g/dL), international system (SI): >=26 gram per liter (g/L);
- •5.2. alanine transaminase (AST) less than or equal to (<=) 2 × upper limit of normal (ULN);
- •5.3. alanine transaminase (ALT) <=2 × ULN
- •5.4. creatinine <=0.8 milligrams per deciliter (mg/dL), SI: <=70.7 micromole per liter (µmol/L), and Serum total immunoglobulins G (IgG) = 600 mg/dL SI: >=6 g/L
- •6. Otherwise healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening.
排除标准
- •1. Currently pregnant with a multiple gestation (twins or more)
- •2. Evidence of fetal anemia prior to randomization in the current pregnancy
- •3. Current uncontrolled hypertension
- •4. History of myocardial infarction, unstable ischemic heart disease, or stroke
- •5. Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- •6. Has inflammatory or autoimmune diseases requiring immunosuppressive therapies that may jeopardize the safety of the participant
- •7. Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months
- •8. Is currently receiving systemic corticosteroids or other immunosuppressants for disorders unrelated to the pregnancy
- •9. Has received or planning to receive plasmapheresis, immunoadsorption therapy, intravenous immunoglobulin (IVIg), or any immunoglobulin (Ig)G fragment crystallizable (Fc)
- •10. -related protein therapeutics during the current pregnancy
- •11. Has a severe infection including opportunistic infections
- •12. Presence of abnormal (protocol-specified) hematologic laboratory values during screening
- •13. History of severe preeclampsia prior to GA Week 34 or severe fetal growth restriction (estimated fetal weight <3rd percentile, based on local fetal growth normative standards) in a previous pregnancy
研究者
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