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NCT06312644 · ClinicalTrials.gov registry record

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

A clinical trial of Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.

Recruiting
Registry status
75
Enrollment target
8
Study locations

NCT06312644: Recruiting study of Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.

NCT06312644 is a study of Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH) that is actively recruiting participants, run by Alexion Pharmaceuticals. The registered enrollment target is 75 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (91% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06312644, a study of Pregnancy and Paroxysmal Nocturnal Hemoglobinuria (PNH), is actively recruiting participants, sponsored by Alexion Pharmaceuticals.

RECRUITING
Registry status
75 participants
Enrollment target
8
Study locations

Study 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.

Primary Outcome

Pregnancy outcomes

Conditions Studied

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

Interventions

  • DRUG Ultomiris

Study Locations (8)

Other

  • Research Site - Paris
  • Research Site - Rome
  • Research Site - Seoul
  • Research Site - Seoul
  • Research Site - London

Massachusetts

  • Research Site - Boston

Victoria

  • Research Site - Melbourne

Norte-Westfalia

  • Research Site - Essen

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2024-12-16
Est. Completion 2034-07-11
Alexion Pharmaceuticals

162 total trials

What NCT06312644 shows while recruiting

NCT06312644 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (91% lower).

The record links to 6 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Ultomiris is the first listed.

NCT06312644 lists 8 locations in 4 states (Other, Massachusetts, Victoria).

Frequently Asked Questions

What is clinical trial NCT06312644 about?

NCT06312644 is a clinical study titled "Study of Ultomiris® (Ravulizumab) Safety in Pregnancy". 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...

What is the current status of trial NCT06312644?

This trial is currently recruiting. The enrollment target is 75 participants. The study started on 2024-12-16. Estimated completion is 2034-07-11.

What conditions does trial NCT06312644 study?

This clinical trial studies the following conditions: Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Generalized Myasthenia Gravis (gMG), Neuromyelitis Optica Spectrum Disorder (NMOSD), Ultomiris-exposed Pregnant/ Postpartum.

What interventions are being tested in trial NCT06312644?

The interventions under investigation include: Ultomiris (DRUG).

Who is sponsoring clinical trial NCT06312644?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06312644 being conducted?

This trial has 8 study locations across Massachusetts, Victoria, Norte-Westfalia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Pregnancy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06312644's enrollment target sits among peer trials

75 130th of 191 higher than 61 of 191 other Pregnancy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06312644

Source: ClinicalTrials.gov NCT06312644, the US trial registry maintained by the National Library of Medicine. NCT06312644 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.