Safety of Ultomiris during pregnancy
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
This study looks at how safe Ultomiris is for pregnant women and their babies to see if it causes any problems during pregnancy and breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Sex | Female |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT06312644 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on pregnancy outcomes and maternal complications in women exposed to Ultomiris during pregnancy and breastfeeding. It will assess both maternal health and the effects on the developing fetus and infant through the first year of life. The study will collect both prospective and retrospective data to provide a comprehensive understanding of the risks associated with Ultomiris exposure in these populations.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have been exposed to Ultomiris and have a qualifying medical condition.
Not a fit: Patients who are not pregnant or have not been exposed to Ultomiris will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of Ultomiris for pregnant women and their infants, potentially guiding treatment decisions.
How similar studies have performed: While studies on drug safety during pregnancy are common, this specific focus on Ultomiris exposure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 6 other locations
- Research Site — Boston, Massachusetts, United States (Recruiting)
- Research Site — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Research Site — Paris, France (Recruiting)
- Research Site — Essen, Norte-Westfalia, Germany (Recruiting)
- Research Site — Rome, Italy (Recruiting)
- Research Site — Seoul, South Korea (Active_not_recruiting)
- Research Site — London, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Sydney Williams — North American Coordinating Center (NACC)
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.