Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT04057703
Description:
Through this program, a coordinated and centralized analysis of reliable pharmacovigilance data will be transmitted in real time to the National Agency for Medicines. It will enable National Agency for Medicines to ensure the safe use of these treatments for the pediatric population, vulnerable, and optimize monitoring in the short and long term identified or potential risks of these treatments on a developing immune system. It will also ensure the monitoring of off-label or Temporary Therapeutic Protocol / Temporary recommendation for use prescriptions and to argue recommendations for good use. For treatments whose benefit will be confirmed, these results will be useful to the medical community to define the best second-line therapeutic strategy.
Study:
NCT04057703
Study Brief:
Balance Benefit / Risk of Immunomodulatory Treatments at the Child and Adolescent for Autoimmune Cytopenia.