Exstension of the international study on efficacy and safety of I10E in CIDP patients

Phase 1

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP); MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005558-31-DE
• Lead Sponsor: FB BIOTECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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:
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.
10. History of kidney transplantation, nephrotic syndrome (defined
as proteinuria >3.5 g per 24 hours accompanied by
hypoalbuminemia and edema), or any acute or chronic kidney
disease that in the opinion of the investigator and/or
nephrologist would preclude the use of I10E and/or interfere
with the assessment of the safety and efficacy of I10E.
AND/OR
Chronic kidney disease (CKD) for more than 3 months as
documented by at least one of the following:
• glomerular filtration rate (GFR) <60 mL/min/1.73m2
measured according to the Modified Diet in Renal
Disease (MDRD) formula
AND/OR
• urine protein reagent strip: =2 crosses
AND/OR
• urine protein reagent strip: one cross with one of the following:
o albumin excretion rate (AER) >300 mg/24 hours
or protein excretion rate (PER) >500 mg/24 hours
(24h-urine collection)
OR
o albumin to creatinine ratio (ACR) >30 mg/mmol
or protein to creatinine ratio (PCR) >50 mg/mmol
(spot urine sample).
11. Serum levels of alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) >2 times upper limit of normal (ULN)
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 oral 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).
14. Any other serious medical condition that would interfere with
the clinical assessment of CIDP or use of I10E or preven

Study & Design

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