Clinical Trials Logo

Clinical Trial Summary

The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.


Clinical Trial Description

Primary Efficacy Variable The primary variable is the number of serious, acute, bacterial infections/subject/year, and it will be based on the total of all of the following events as defined by the FDA: bacterial Pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscess, and bacterial meningitis.

Secondary Efficacy Variables Secondary efficacy will be determined by using the following variables: number of days of work/school missed because of infection per subject year; number and days of hospitalizations because of infection per subject year; number of visits to physicians for acute problems and/or number of visits to hospital emergency rooms per subject year; other infections documented by fever or a positive result on a radiograph and/or culture; number of infectious episodes per subject per year; number of days on therapeutic antibiotics.These data will be entered into the subject diary, confirmed by the physician, and entered on the electronic-CRF (e-CRF).

Safety Variables. The variables used to assess safety will be the following: adverse events (AEs); vital signs; clinical laboratory tests and Direct Coombs' Test; transmission of viruses; physical examination.

Test product, dose/mode of administration, batch number(s): The GAMMAPLEX dose is 300-800 mg/kg/infusion (milligram per killgram per infusion) every 21 or 28 days, intravenously. At least 2 batches will be used in this study and no more than 1 batch in any given infusion.

Duration of treatment:

The total duration of treatment is 12 months. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00278954
Study type Interventional
Source Bio Products Laboratory
Contact
Status Completed
Phase Phase 3
Start date January 2006
Completion date November 2007

See also
  Status Clinical Trial Phase
Completed NCT04561115 - A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency Phase 3
Recruiting NCT06355323 - Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France N/A
Completed NCT04566692 - A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency Phase 4
Completed NCT01465958 - Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency Phase 4
Completed NCT01581593 - Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID) Phase 3
Completed NCT02881437 - IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia Phase 4
Recruiting NCT06092528 - Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency N/A
Active, not recruiting NCT03576742 - Severe Immune Cytopenia Registry Www.Sic-reg.Org
Completed NCT03907241 - CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL Phase 3
Not yet recruiting NCT04902807 - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Completed NCT02806986 - Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency Phase 3
Completed NCT03339778 - The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations N/A
Enrolling by invitation NCT00895271 - Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Recruiting NCT03206099 - NIAID Centralized Sequencing Protocol
Completed NCT02503293 - A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push Phase 4
Recruiting NCT03610802 - Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies
Completed NCT03815357 - What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
Completed NCT02269163 - Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% Phase 3
Terminated NCT03733249 - Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study Phase 1/Phase 2
Completed NCT02604810 - Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency Phase 3