Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCerbaXpert
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Pregiferon
Other interventionThis Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: pregnant womenOther 1 intervention
Trial outcomes
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.
Time frame
30 monthsLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: