NCT06312644 Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
| NCT ID | NCT06312644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Ultomiris-exposed Pregnant/ Postpartum |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2034-07-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-12-16 with a primary completion date of 2034-07-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
Inclusion Criteria: * 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 \[SmPC\]) Exclusion Criteria: * Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study
Contact & Investigator
Sydney Williams
PRINCIPAL INVESTIGATOR
North American Coordinating Center (NACC)
Frequently Asked Questions
Who can join the NCT06312644 clinical trial?
This trial is open to female participants only, studying Ultomiris-exposed Pregnant/ Postpartum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06312644 currently recruiting?
Yes, NCT06312644 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT06312644 trial being conducted?
This trial is being conducted at Boston, United States, Melbourne, Australia, Paris, France, Essen, Germany and 3 additional locations.
Who is sponsoring the NCT06312644 clinical trial?
NCT06312644 is sponsored by Alexion Pharmaceuticals, Inc.. The principal investigator is Sydney Williams at North American Coordinating Center (NACC). The trial plans to enroll 75 participants.