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

NCT ID: NCT06371235

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pregnant women

Pregnant woman over 18 years old

\- Woman whose gestational age is less than 30 weeks

Group Type OTHER

Pregiferon

Intervention Type OTHER

This Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier

Interventions

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Pregiferon

This Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CerbaXpert

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2024-A00739-38

Identifier Type: -

Identifier Source: org_study_id

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