NCT06299748 A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
| NCT ID | NCT06299748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | argenx |
| Condition | Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 279 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 279 participants in total. It began in 2023-11-30 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days. * Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian). Exclusion Criteria: * None
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06299748 clinical trial?
This trial is open to female participants only, studying Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06299748 currently recruiting?
Yes, NCT06299748 is actively recruiting participants. Contact the research team at Clinicaltrials@argenx.com for enrollment information.
Where is the NCT06299748 trial being conducted?
This trial is being conducted at Morgantown, United States, Bochum, Germany, Roma, Italy, Barcelona, Spain.
Who is sponsoring the NCT06299748 clinical trial?
NCT06299748 is sponsored by argenx. The trial plans to enroll 279 participants.