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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06312644
Other study ID # D9289C00007
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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