Pregiferon
OtherThis Study aims to study the transmission of anti-interferon alpha autoantibodies from mother to child viaplacental barrier
Not Yet Recruiting
NCT Number: NCT06371235
Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.
Time frame: 30 months
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.
Sponsors and collaborators
Lead sponsor
CerbaXpert
Other
Registry information
Acronym: Pregiferon
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2027
- First posted
- Apr 17, 2024
- Registry last updated
- Apr 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.