Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Pregnancy Clinical Trial

Official title:

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312644
• Other study ID #: D9289C00007
• Status: Not yet recruiting
• Start date: March 29, 2024
• Est. completion date: October 21, 2033

Study information

• Verified date: March 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: Alexion Pharmaceuticals, Inc. (Sponsor)
• Phone: 1-855-752-2356
• Email: clinicaltrials[@]alexion.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 21, 2033
• Est. primary completion date: October 21, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Hemolytic Uremic Syndrome
• Atypical Hemolytic Uremic Syndrome (aHUS)
• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Hemolytic-Uremic Syndrome
• Myasthenia Gravis
• Neuromyelitis Optica
• Paroxysmal Nocturnal Hemoglobinuria (PNH)
• Pregnancy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Pregnancy Complications	Pregnancy outcomes	Up to 4 weeks post-delivery
Primary	Number of Maternal Complications	Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage	Up to 4 weeks post-delivery
Primary	Fetal/Infant Outcomes	Fetal (in Utero)/infant (for Live Born Births) may include major congenital malformation (MCMs), full-term birth, preterm birth, low birth weight, size for gestational age, neonatal death, perinatal death, infant death, serious and severe infections of infants, infant hospitalization, growth delays, and abnormal postnatal growth and development	In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)