ONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS

FB SA0 sites23 target enrollmentStarted: April 13, 2007Last updated: April 4, 2022

Conditions

Trial Snapshot

No summary available.

•1.Signed and dated informed consent form
•2.Have a primary immunodeficiency (e.g. X-linked agammaglobulinemia ; common variable immunodeficiency ; hyper IgM syndrome)
•3.Need to have an immunoglobulin replacement therapy
•4.Age from 12 to 75 years old
•5.For women of childbearing potential, a negative pregnancy test before inclusion and a medically-acceptable method of birth control throughout the study are required
•6.Covered by healthcare insurance in accordance with local requirements
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Known allergy or serious adverse reaction to any IVIG
•2.Known allergy to mannitol, glycine or polysorbate 80
•3.Chronic renal insufficiency or serum creatinine level > 120µmol/l
•4.Protein-loosing enteropathy characterised by serum protein level < 60 g/l and serum albumin level < 30 g/l
•5.Nephrotic syndrome characterised by proteinuria = 3.5 g/24 hours, serum protein level < 60 g/l and serum albumin level < 30 g/l
•6.Isolated deficiency of a IgG subclass with a normal total serum IgG level
•7.Having IgA deficiency, and anti-IgA antibodies have been detected
•8.Allogeneic haematopoeitic stem cells transplantation within the last year before infusion
•9.Severe or non-controlled cardiac disease (New York Heart Association stage III and IV)
•10.Long-term immunosuppressive treatment (corticosteroids included)
•11.Use of loop diuretics
•12.Pregnancy or breastfeeding
•13.Participation in another clinical study within 3 weeks prior to the start of study treatment, except in a previous IGNG study
•14.Patients whose use of concomitant medication may interfere with the interpretation of data
•15.Anticipated poor compliance of patient with study procedures

Sponsor

FB SA