Primary Immunodeficiency MedDRA version: 9.1 Level: LLT Classification code 10064859 Term: Primary immunodeficiency syndrome
Conditions
Interventions
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IGNG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin for intravenous
Sponsors
LFB SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the clinical and biological safety of IGNG by considering adverse events in patients treated as per current practice over a 2-year-period for primary immunodeficiency.;Secondary Objective: The secondary objectives of the study are: - to evaluate clinical and biological efficacy of IGNG - to describe IGNG safety with clinical and biological parameters - to describe IGNG tolerability by the use of premedication before infusion. ;Primary end point(s): 1. Adverse event frequency, nature, duration and time of onset during and after IGNG administration, occurring during the study, overall and by subgroups: - Infusional AEs (ie, an AE temporally associated with an infusion) - Others AEs 2. Proportion of infusions with at least one infusional AE | — |
Countries
France
Outcome results
None listed