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NCT06299748 · ClinicalTrials.gov registry record
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
A clinical trial of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by argenx.
- Recruiting
- Registry status
- 279
- Enrollment target
- 4
- Study locations
NCT06299748: Recruiting study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by argenx.
NCT06299748 is a study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy that is actively recruiting participants, run by argenx. The registered enrollment target is 279 participants, above the 182-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (53% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06299748, a study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- 279 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
Primary Outcome
Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod
Study Locations (4)
Other
- Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1) - Bochum
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma
- Hospital Universitari Vall d'Hebron - Barcelona
West Virginia
- United BioSource LLC - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2033-12 |
What NCT06299748 shows while recruiting
NCT06299748 is an observational study that tracks outcomes without assigning an intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 182-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (53% higher).
The record links to 2 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod is the first listed.
NCT06299748 reports a single indexed study location in Other, West Virginia.
Frequently Asked Questions
What is clinical trial NCT06299748 about?
NCT06299748 is a clinical study titled "A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.". This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enrol...
What is the current status of trial NCT06299748?
This trial is currently recruiting. The enrollment target is 279 participants. The study started on 2023-11-30. Estimated completion is 2033-12.
What conditions does trial NCT06299748 study?
This clinical trial studies the following conditions: Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy.
What interventions are being tested in trial NCT06299748?
The interventions under investigation include: Efgartigimod (BIOLOGICAL).
Who is sponsoring clinical trial NCT06299748?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06299748 being conducted?
This trial has 4 study locations across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06299748's enrollment target sits among peer trials
279 6th of 32 higher than 27 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
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