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NCT01150240 Clinical Trial

Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Primary Immunodeficiency Disease Clinical Trial

Official title:
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01150240
Other study ID # PID_CH_Registry06
Secondary ID
Status Enrolling by invitation
Phase N/A
First received June 23, 2010
Last updated May 12, 2016
Start date October 2006

Study information
Verified date May 2016
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 800
Est. completion date
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital Basel Basel
Switzerland University Hospital Bern Bern
Switzerland University Children's Hospital Geneva Geneva
Switzerland University Hospital Lausanne Lausanne
Switzerland Children's Hospital of Eastern Switzerland and Cantonal Hospital St. Gallen
Switzerland University Children's Hospital Zurich Zurich

Sponsors (6)
Lead Sponsor Collaborator
University of Zurich Cantonal Hospital of St. Gallen, University Hospital, Geneva, University of Basel, University of Bern, University of Lausanne

Country where clinical trial is conducted

Switzerland, 

See also
  Status Clinical Trial Phase
Recruiting NCT03677557 - 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 NCT02627300 - 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