SAFETY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, WHEN ADMINISTERED TO PRIMARY IMMUNODEFICIENT PATIENTS, AT A PROGRESSIVELY INCREASED FLOW RATE

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-012036-32-FR
• Date of registration: 28/05/2009
• Prospective Registration: Yes
• Primary sponsor: LFB BIOTECHNOLOGIES
• Public title: SAFETY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, WHEN ADMINISTERED TO PRIMARY IMMUNODEFICIENT PATIENTS, AT A PROGRESSIVELY INCREASED FLOW RATE
• Scientific title: SAFETY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, WHEN ADMINISTERED TO PRIMARY IMMUNODEFICIENT PATIENTS, AT A PROGRESSIVELY INCREASED FLOW RATE
• Date of first enrolment: 30/07/2009
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012036-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
1.Patient already included in study IGNG-0629 and who still meets all the IGNG-0629 inclusion criteria reported here below :
a.Informed consent forms signed and dated for study IGNG-0629 and for serum reference sample.
b.Patient with primary immunodeficiency (eg X-linked agammaglobulinemia, common variable immunodeficiency, hyper IgM syndrome)
c.Need to have an immunoglobulin replacement therapy.
d.Age from 12 to 75 years old.
e.For women of childbearing potential, a negative pregnancy test before inclusion and a medically-acceptable method of birth control throughout the study are required
f.Patient covered by healthcare insurance in accordance with local requirements
2.Having received the specific information and signed the informed consent form for this new protocol.
3.Having undergone the last 4 IGNG infusions at a flow rate of 4 m/kg/h and without any IGNG related adverse event.

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. Patient who repeatedly requires a premedication with antihistamines, corticosteroids, or antipyretics before the IGNG infusion.
2. Patient who meet one of the IGNG-0629 exclusion criteria listed below:
a. Known allergy or serious adverse reaction to any IVIG
b. Known allergy to mannitol, glycine or polysorbate 80
c. Chronic renal insufficiency or serum creatinine level > 120 µmol/l in adults or creatinine clearance < 80 ml/min/1,73m2 (calculated with Schwartz formula) in adolescent patients
d. Protein-loosing enteropathy characterised by serum protein level < 60 g/l and serum albumin level < 30 g/l
e.Nephrotic syndrome characterised by proteinuria ? 3.5 g/24 hours, serum protein level < 60 g/l and serum albumin level < 30 g/l
f. Isolated deficiency of a IgG subclass with a normal total serum IgG level
g. Having IgA deficiency, and anti-IgA antibodies have been detected
h. Allogeneic haematopoeitic stem cells transplantation within the last year before infusion
i. Severe or non-controlled cardiac disease (New York Heart Association stage III and IV)
j. Long-term immunosuppressive treatments (corticosteroids included)
k. Use of loop diuretics (furosemide, bumetanide, piretanide)
l. Pregnancy or breastfeeding
m. Participation in another clinical study within 3 weeks prior to the start of study treatment, except in a previous IGNG study
n. Patients whose use of concomitant medication may interfere with the interpretation of data
o. Anticipated poor compliance of patient with study procedures




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PRIMARY IMMUNODEFICIENCY
MedDRA version: 9.1 Level: LLT Classification code 10064859 Term: Primary immunodeficiency syndrome

Intervention(s)

Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Product Code: IGNG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): •Number of infusions administered and proportion of those with one or more IMP related adverse events, by highest flow rate reached during the infusion.

Main Objective: To assess the clinical and biological safety of IGNG 5% when administered in patients with primary immunodeficiency at a progressively increased infusion flow rate, up to 8 ml/kg/h.

Secondary Objective: •To evaluate the clinical and biological efficacy of IGNG
•To evaluate the time saved by the increase of infusion flow rate

Secondary ID(s)

IGNG-0724