Clinical Trials Logo

Clinical Trial Summary

Study Design:

This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.


Clinical Trial Description

This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.

The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01859754
Study type Observational
Source Octapharma
Contact
Status Completed
Phase
Start date May 21, 2013
Completion date May 22, 2019

See also
  Status Clinical Trial Phase
Completed NCT03939533 - Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases Phase 3
Recruiting NCT03266627 - Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection Phase 2
Recruiting NCT03266640 - Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) Phase 2
Recruiting NCT03148028 - Immunological Characteristics of Patients With PID and IBD N/A
Active, not recruiting NCT04354818 - Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)
Completed NCT03988426 - Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases Phase 3
Completed NCT01888484 - Study of Octanorm Subcutaneous IG in Patients With PID Phase 3
Completed NCT01131858 - Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency Phase 1/Phase 2
Completed NCT03211689 - The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease N/A
Terminated NCT01883921 - Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Recruiting NCT03266653 - EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection Phase 2
Completed NCT02327351 - TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID Phase 2/Phase 3
Completed NCT03618147 - Primary Immunodeficiency in Kuwait
Recruiting NCT04197596 - Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) Phase 1/Phase 2
Recruiting NCT03422614 - Pathophysiology of Inborn Immunodeficiencies N/A
Completed NCT02888535 - Intensive Care Unit and Secondary and Primary Immune Deficiency
Recruiting NCT04232085 - Reduced Intensity BMT for Immune Dysregulatory and Bone Marrow Failure Syndromes Using Post-Transplant Cyclophosphamide Phase 2
Active, not recruiting NCT03037359 - A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
Completed NCT03069079 - Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study N/A
Recruiting NCT03414528 - Identification of New Inborn Errors of Immunity N/A