Primary Immunodeficiency Disease Clinical Trial
Official title:
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland
A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).
The project aims to compile clinical and laboratory data of patients with primary
immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and
therapy. The online technology offers features not available in former databases such as
access control,security functionality, and maintenance of data integrity during transactions
and system errors, online back up, online optimization, scalability and online SQL-queries
as well as a long term documentation of patients.
Furthermore the database can be used for the submission and storage of molecular diagnostic
results and thus allow the compilation of genotype and phenotype observations, which is of
essential and immediate use for the patient himself and patient care. An attending physician
may gain information on similar cases of a rare PID disease in Switzerland and European
countries and use these insights for therapy. In addition, it will be possible to obtain an
insight on side effects. Thus, the system also meets the requirements of an optimal platform
for Phase IV studies of post-licensing drug surveillance-programs.
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Observational Model: Cohort
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment
|
Phase 4 | |
| Completed |
NCT02810444 -
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
|
Phase 3 | |
| Recruiting |
NCT04944979 -
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
|
Phase 3 | |
| Completed |
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Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial
|
Phase 3 | |
| Not yet recruiting |
NCT03252548 -
Pediatric Primary Immunodeficiency Disease (PID) in China
|
N/A | |
| Completed |
NCT03961009 -
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
|
Phase 3 | |
| Completed |
NCT04842643 -
An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
|
Phase 3 | |
| Not yet recruiting |
NCT06089122 -
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG
|
Phase 3 | |
| Not yet recruiting |
NCT06150833 -
Efficacy and Safety and Pharmacokinetics of Boya IVIG
|
Phase 3 |