Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultomiris.
- Who it may be relevant to
- Registry conditions: Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS). Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France, Germany, Italy +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Overview
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.
Detailed description
This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.
Interventions
- Drug Ultomiris
Participants exposed to Ultomiris at any point during the 40 weeks prior to conception (LMP+14 days) or at any point during pregnancy or breastfeeding up to 52 weeks after birth.
Primary outcome measures
- Pregnancy Complications [Time frame: Up to 4 weeks post-delivery]
- Maternal Complications [Time frame: Up to 4 weeks post-delivery]
- Fetal/Infant Outcomes [Time frame: In utero through 52 weeks of age after exposure to Ultomiris (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Research Site — Boston
Australia · 1 center
- Research Site — Melbourne
France · 1 center
- Research Site — Paris
Germany · 1 center
- Research Site — Essen
Italy · 1 center
- Research Site — Rome
South Korea · 1 center
- Research Site — Seoul
United Kingdom · 1 center
- Research Site — London
Identifiers
NCT: NCT06312644 · D9289C00007