ClinicaliQ Trial Snapshot
- Study of Ultomiris® (Ravulizumab) Safety in Pregnancy — Recruiting • Oncology • NCT06312644.
- What is being tested: Ultomiris® (Ravulizumab), a C5 complement inhibitor, is being evaluated for safety outcomes in pregnant women and their offspring, including maternal complications, fetal development, and neonatal/infant outcomes following in utero exposure.
- Patient eligibility overview: The study includes pregnant women who have been exposed to Ultomiris during pregnancy, with follow-up of maternal health and offspring assessed from in utero through infancy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.
Eligibility Snapshot
- : * Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified). * Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate). * Willing to provide contact information for the participant. * Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations. * Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records. * Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure [prior to conception as LMP+14 days, or during breastfeeding].) * Use of Ultomiris per local product information (i.e., United States Prescribing Information [USPI] or summary of product characteristics [SmPC])
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.