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Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier (Pregiferon)

C

CerbaXpert

Status

Not yet enrolling

Conditions

Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons

Treatments

Other: Pregiferon

Study type

Interventional

Funder types

Other

Identifiers

NCT06371235
2024-A00739-38

Details and patient eligibility

About

The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy.

Enrollment

250 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant woman over 18 years old
  • Woman whose gestational age is less than 30 weeks.
  • Having agreed to carry out an assay of anti-IFN alpha IgG auto-Ac before 30 weeks
  • Give birth in the inclusion center
  • Suffering from a pathology frequently associated with the presence of these anti-autoantibodies IFN alpha (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, auto-thyroid disease immune system such as Graves' disease, Hashimoto's thyroiditis) or knowing its positive anti-IFN alpha autoantibody status
  • Affiliated with the Social Security system

Exclusion criteria

  • Patient who underwent a blood transfusion less than 2 months ago
  • Patient who received an organ transplant
  • Patient undergoing immunotherapy, stem cell therapy and/or other malignancy maternal, under heavy treatment (chemotherapy) less than 6 months before inclusion

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

pregnant women
Other group
Description:
Pregnant woman over 18 years old - Woman whose gestational age is less than 30 weeks
Treatment:
Other: Pregiferon

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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