EUCTR2017-004958-42-ES进行中（未招募）1 期
A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
入选标准
- •1.Able to understand and voluntarily provide written informed consent to participate in the study.
- •2.Female and =18 years of age.
- •3.Pregnant with an estimated GA of 8 to 13 weeks.
- •4.A previous pregnancy with a gestation that included at least one of the following at =24 weeks gestation:
- •a.Severe fetal anemia, defined as hemoglobin =0.55 multiples of the median (MoM) for GA **refer to table on page 12 of the protocol.
- •b.Fetal hydrops (ascites) with an MCA-PSV MoM =1.5
- •c.Stillbirth with fetal or placental pathology indicative of HDFN
- •5.Maternal alloantibody titers for anti-D of =32, or anti-Kell titers =8.
- •6.Free fetal deoxyribonucleic acid (DNA) consistent with an antigen positive fetus (blood sample taken from mother).
- •7.Maternal evidence for immunity to measles mumps, rubella, and varicella, as documented by laboratory reports obtained from medical history or serologies performed during Screening.
- •8.Screening IgG and albumin levels within the laboratory normal range for gestational age of pregnancy.
- •9.Willing to receive standard of care with IUT if clinically indicated.
- •10.Agree to recommended vaccinations per local standard of care for both mother and child throughout the course of the study.
- •11.Willing to forego participation in another clinical trial of an investigational therapy for the duration of their participation in the current study.
- •12.Willing to consent to a 6 month safety follow-up period for the patient and a 24 month safety follow-up period for the neonate/infant.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Currently pregnant with multiples (twins or more).
- •2.Pre-eclampsia in current pregnancy or history of pre-eclampsia in a previous pregnancy.
- •3.History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy, or genital herpes.
- •4.Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C during Screening.
- •5.Active infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior infection or exposure, but without clinical signs and symptoms of active infection is acceptable).
- •6.Active infection with tuberculosis as evidenced by positive QuantiFERON-TB testing.
- •7.Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted).
- •8.History of drug allergy, hypersensitivity, or intolerance to any drug product that, in the opinion of the Investigator, would compromise the safety of the patient.
- •9.In the Investigator’s opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
- •10.Smoking during pregnancy.
- •11.Received plasmapheresis and/or IVIG during the current pregnancy for treatment of HDFN.
- •12.Received an investigational drug and/or device within 30 days or 5 half-lives prior to receiving the first IV infusion of M281.
- •13.A history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine/metabolic, immunologic, severe or recurrent infections (eg, frequent hospitalized pneumonia), dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition or issue that, in the opinion of the Investigator, would jeopardize the safety of the patient or fetus/neonate/infant or the validity of the study results.
研究者
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