Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Study Identifier:
D9289C00007
ClinicalTrials.gov Identifier:
NCT06312644
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Other
  • Pregnancy
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Atypical Hemolytic Uremic Syndrome (aHUS)
  • Generalized Myasthenia Gravis (gMG)
  • Unmapped
Study Drug
  • Drug: Ultomiris
Date
Dec 2024 - Jul 2034
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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
Sex
Female
Age
N/A

Study Details

Medical Condition
  • Other
  • Pregnancy
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Atypical Hemolytic Uremic Syndrome (aHUS)
  • Generalized Myasthenia Gravis (gMG)
  • Unmapped
Study Drug
  • Drug: Ultomiris
Date
Dec 2024 - Jul 2034
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Boston, Massachusetts, United States, 02210
Status
Recruiting
Location
Research Site
Melbourne, Victoria, Australia, 3050
Status
Not yet recruiting
Location
Research Site
Paris, France, 75475
Status
Active, not recruiting
Location
Research Site
Essen, Norte-Westfalia, Germany, D-45147
Status
Recruiting
Location
Research Site
Rome, Italy, 00168
Status
Active, not recruiting
Location
Research Site
Seoul, Republic of Korea
Status
Active, not recruiting
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