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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06312644




Registration number
NCT06312644
Ethics application status
Date submitted
9/03/2024
Date registered
15/03/2024
Date last updated
12/09/2025

Titles & IDs
Public title
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Scientific title
Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
Secondary ID [1] 0 0
D9289C00007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ultomiris-exposed Pregnant/ Postpartum 0 0
Pregnancy 0 0
Paroxysmal Nocturnal Hemoglobinuria (PNH) 0 0
Atypical Hemolytic Uremic Syndrome (aHUS) 0 0
Generalized Myasthenia Gravis (gMG) 0 0
Neuromyelitis Optica Spectrum Disorder (NMOSD) 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Ultomiris

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pregnancy Complications
Timepoint [1] 0 0
Up to 4 weeks post-delivery
Primary outcome [2] 0 0
Maternal Complications
Timepoint [2] 0 0
Up to 4 weeks post-delivery
Primary outcome [3] 0 0
Fetal/Infant Outcomes
Timepoint [3] 0 0
In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)

Eligibility
Key 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])
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/07/2034
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital Clinical Haematology - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Norte-Westfalia
Country [4] 0 0
Italy
State/province [4] 0 0
Rome
Country [5] 0 0
South Korea
State/province [5] 0 0
Seoul
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sydney Williams
Address 0 0
North American Coordinating Center (NACC)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc. (Sponsor)
Address 0 0
Country 0 0
Phone 0 0
1-855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06312644