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

NCT06371235 | Not Yet Recruiting

• 1 other identifier: 2024-A00739-38
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.

  A placental transfer will be defined by the presence of anti-IFN alpha IgG auto Ab in the blood. of the umbilical cord. The transfer frequency will be calculated with its overall 95% confidence interval and by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women by pathology (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, autoimmune thyroid disease such as Graves' disease, Hashimoto's thyroiditis), in HIV-positive women.

  30 months

Study Arms (1)

pregnant women

OTHER

Pregnant woman over 18 years old \- Woman whose gestational age is less than 30 weeks

Other: Pregiferon

Interventions

Pregiferon OTHER

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

pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Patient who underwent a blood transfusion less than 2 months ago
• Patient who received an organ transplant

Sponsors & Collaborators

• CerbaXpert: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 17, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04