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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 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.

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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.

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

Sponsor

Alexion Pharmaceuticals

162 total trials

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What the Registry Record Tells You About NCT06312644

The ClinicalTrials.gov registry entry for NCT06312644 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (91% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.