Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Last updated: January 6, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Anemia

Neuropathy

Treatment

Ultomiris

Ultomiris

Clinical Study ID

NCT06312644
D9289C00007
  • Female

Study 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

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 ethicscommittee requirements) must be obtained prior to the participant's enrollment. Ifthe participant is a minor, consent must be obtained from the parent or legalguardian, 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 tothe study, upon request, if applicable to current local regulations.

  • Diagnosed with an indication for which Ultomiris is approved, based on HCP ormedical records.

  • Exposed to Ultomiris at any point during the defined exposure window based on HCP ormedical record documentation. (If exact exposure dates are unknown, the reportermust be able to specify or estimate trimester or timing of exposure [prior toconception as LMP+14 days, or during breastfeeding].)

  • Use of Ultomiris per local product information (i.e., United States PrescribingInformation [USPI] or summary of product characteristics [SmPC])

Exclusion

Exclusion Criteria:

  • Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectualdisabilities) will be excluded from this study

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Ultomiris
Phase:
Study Start date:
December 18, 2024
Estimated Completion Date:
October 24, 2034

Study 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.

Connect with a study center

  • North American call center (NACC)

    Boston, Massachusetts 02210
    United States

    Active - Recruiting

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