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

Phase 1

• Conditions: Primary Immunodeficiency; MedDRA version: 9.1Level: LLTClassification code 10064859Term: Primary immunodeficiency syndrome

• Registration Number: EUCTR2007-001410-17-FR
• Lead Sponsor: FB SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-13
• Study Completion: 2011-01-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- to evaluate clinical and biological efficacy of IGNG<br>- to describe IGNG safety with clinical and biological parameters<br>- to describe IGNG tolerability by the use of premedication before infusion.<br>;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:<br>- Infusional AEs (ie, an AE temporally associated with an infusion)<br>- Others AEs<br>2. Proportion of infusions with at least one infusional AE