RECRUITING

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Conditions

Ultomiris-exposed Pregnant/ Postpartum Pregnancy Paroxysmal Nocturnal Hemoglobinuria (PNH)Atypical Hemolytic Uremic Syndrome (aHUS)Generalized Myasthenia Gravis (gMG)Neuromyelitis Optica Spectrum Disorder (NMOSD)Ultomiris PNH aHUS gMG NMOSD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Quick Facts

Study Start:2024-09-30

Study Completion:2033-11-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06312644

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \[SmPC\])	* 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

Inclusion Criteria

Exclusion 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 \[SmPC\])

* 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

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356

clinicaltrials@alexion.com

Principal Investigator

Sydney Williams

PRINCIPAL_INVESTIGATOR

North American Coordinating Center (NACC)

Study Locations (Sites)

North American call center (NACC)

Boston, Massachusetts, 02210

United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Sydney Williams, PRINCIPAL_INVESTIGATOR, North American Coordinating Center (NACC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2033-11-29

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2033-11-29

Terms related to this study

Keywords Provided by Researchers

Ultomiris
pregnancy
PNH
aHUS
gMG
NMOSD

Additional Relevant MeSH Terms

Ultomiris-exposed Pregnant/ Postpartum
Pregnancy
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Generalized Myasthenia Gravis (gMG)
Neuromyelitis Optica Spectrum Disorder (NMOSD)