Clinical Trials Logo

Clinical Trial Summary

This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01888484
Study type Interventional
Source Octapharma
Contact
Status Completed
Phase Phase 3
Start date March 2014
Completion date June 9, 2020

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
Completed NCT01859754 - Octagam 5% Versus Comparator Post Marketing Trial
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 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