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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: 21 August 2017
Main ID:  EUCTR2013-005558-31-ES
Date of registration: 16/12/2014
Prospective Registration: Yes
Primary sponsor: LFB BIOTECHNOLOGIES
Public title: Exstension of the international study on efficacy and safety of I10E in CIDP patients
Scientific title: International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2
Date of first enrolment: 18/02/2015
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005558-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: single arm If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
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 Germany Italy Mexico Morocco Spain Tunisia Turkey
United Kingdom
Contacts
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 ? LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33169 82 70 10
Email: neuharte@lfb.fr
Affiliation:  LFB BIOTECHNOLOGIES
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 ? LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33169 82 70 10
Email: neuharte@lfb.fr
Affiliation:  LFB BIOTECHNOLOGIES
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female patient aged 18 years or more.
2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ?1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
3. Covered by national healthcare insurance system as required
by local regulations.
4. Written informed consent obtained prior to any study-related
procedures.
Are the trial subjects under 18? no
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Based on follow-up and results of analyses performed in PRISM
I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
study if none of the following criteria is met:
1. History of severe allergic reaction or serious adverse reaction to
any Ig.
2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
6. History of personal or familial congenital thrombophilia or acquired thrombophilia.
7. Factors contributing to venous stasis such as long-term bed confinement.
8. Body mass index (BMI) ?40 kg/m².
9. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria ?3.5 g/24 hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
10. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
11. Serum levels of Alanine aminotransferase (AST) or Aspartate
aminotransferase (ALT) >2 times upper limit of normal range.
12. Any other ongoing disease that may cause chronic peripheral
neuropathy, such as toxin exposure, dietary deficiency,
uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus
erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
13. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception. Effective contraceptives are injectable, patch or combined oestro-progestative or progestative contraceptives, Copper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occlusive caps (diaphragm or
cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.1 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: Human normal 10% immunoglobulin for intravenous administrationn
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The study is descriptive. The primary objective is to assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study.
Primary end point(s): The primary efficacy endpoint will be the responder rate at EOS
visit.
Responders are defined as patients with either:
- No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit.
or
- An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.
Secondary Objective: The secondary objective is to assess the safety of I10E in this patient population.
Timepoint(s) of evaluation of this end point: At the inclusion (baseline), end of study visit
Secondary Outcome(s)
Secondary end point(s): Main secondary efficacy endpoints:
? Change from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
? Responder rate at 24 weeks (visit V9).
? Time to relapse.
? Change from baseline to 24 weeks (Visit V9) and EOS visit in the following scores:
? Grip strength with the Martin Vigorimeter in both hands;
? Rasch-built Overall Disability Scale (R-ODS);
? Medical Research Council (MRC) 12 muscles sum score
(0 to 5) and Rasch-modified MRC (0 to 3).
Other secondary endpoints:
- Percentage of patients at 24 weeks (Visit V9) and EOS visit with no requirement of change in CIDP treatment from baseline.
- Change from baseline to 24 weeks (Visit V9) and EOS visit in Patient and Investigator Clinical Global Impression (CGI).
Timepoint(s) of evaluation of this end point: At the inclusion, at week 24 and at the end of study visit
Secondary ID(s)
2013-005558-31-GB
I10E-1306
Source(s) of Monetary Support
LFB BIOTECHNOLOGIES
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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