Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Launched by ALEXION PHARMACEUTICALS, INC. · Mar 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called Ultomiris (also known as Ravulizumab) in pregnant women and those who have recently given birth. The main goal is to understand how this medication affects pregnancy outcomes, any complications for the mother, and the health of the baby during pregnancy, at birth, and up to one year after birth. This information is important for women who may need to use Ultomiris for conditions like Paroxysmal Nocturnal Hemoglobinuria (PNH) or Atypical Hemolytic Uremic Syndrome (aHUS).

To participate in the study, women must be pregnant or have recently given birth, and they need to have been treated with Ultomiris at some point during their pregnancy. Participants will need to provide consent for their medical information to be shared with the study team. If you or someone you know fits this description and is interested in learning more, joining the study could help improve our understanding of how Ultomiris impacts mothers and their babies. Participants will be monitored throughout the study, and their experiences will contribute valuable data to ensure safer treatments in the future.

Gender

FEMALE

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