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Not yet recruiting NCT06371235

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

No phase Interventional Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregiferon.
Who it may be relevant to
Registry conditions: Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn. [Time frame: 30 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06371235 · 2024-A00739-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗