|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
4 April 2022 |
|
Main ID: |
EUCTR2007-001410-17-FR |
|
Date of registration:
|
13/04/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
LONG-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
|
|
Scientific title:
|
LONG-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 |
|
Date of first enrolment:
|
31/05/2007 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001410-17 |
|
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:
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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:
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
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 administration
Product Code: IGNG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin for intravenous administration
Current Sponsor code: IGNG
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
|
|
Primary Outcome(s)
|
|
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.
|
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
|
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.
|
|
Secondary ID(s)
|
|
IGNG-0629
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 25/04/2007
Contact:
|
|