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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: 24 April 2012
Main ID:  EUCTR2009-017672-24-FI
Date of registration: 10/09/2010
Prospective Registration: Yes
Primary sponsor: CSL Behring GmbH
Public title: This research study will investigate whether the investigational medicine IgPro10 is efficient and safe for patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Scientific title: A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)
Date of first enrolment: 30/11/2010
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017672-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Finland
Contacts
Name: Finnish Office   
Address:  Peltovuorentie 15 F 01690 Vantaa Finland
Telephone: +358408288200
Email: j.dregvaite@pierrelgroup.com
Affiliation:  Pierrel Research Europe GmbH
Name: Finnish Office   
Address:  Peltovuorentie 15 F 01690 Vantaa Finland
Telephone: +358408288200
Email: j.dregvaite@pierrelgroup.com
Affiliation:  Pierrel Research Europe GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
Subjects meeting all of the following inclusion criteria may be enrolled into the study:
• IVIG-untreated subjects: either subjects with newly diagnosed CIDP (developing
over at least 2 months) or subjects with an IVIG treatment interruption for at least 1
year with a progressive disease (deteriorating in the last 2 months) prior to
enrolment
OR
IVIG-pretreated subjects being treated regularly with IVIG:
- on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months
- on a fixed dosage of ± 20 % in the last 6 months
- deteriorating by at least 1 INCAT score point during the Washout Period of up to 10
weeks (except for an increase from 0 to 1 solely due to upper limb score).
• Diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory
or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria
for definite or probable CIDP according to EFNS/PNS guideline.
- IVIG-untreated subjects need an actual diagnosis including electrophysiology.
- IVIG-pretreated subjects need a historic diagnosis.
• Age =18 years.
• Male or female.
• Written informed consent for study participation obtained before undergoing any
study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
• A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with conduction block (ie, upper limb motor weakness without sensory deficit and with a 50%
decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves).
• Monoclonal gammopathy of uncertain significance (MGUS) associated with anti-MAG Immunoglobulin M (IgM) antibodies and subjects with distal acquired demyelinating
symmetric (DADS) neuropathy.
• Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radicolopathy, post-polio-syndrome, M. Parkinson, stroke).
• Current malignancy.
• Cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart
disease, congestive heart failure or severe hypertension.
• History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident).
• Migraine associated with IVIG infusion in the last 3 months prior to enrolment.
• Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).
• Subjects with serum IgA level less than 50% of the lower normal limit.
• Known hyperprolinemia.
• Any condition (including alcohol, drug or medication abuse) that is likely to interfere with evaluation of the study product or satisfactory conduct of the study.
• Plasma exchange 3 months prior to enrolment.
• Treatment with immunomodulatory agents others than steroids, methotrexate or azathioprine (e.g. interferon, TNF-a inhibitors) within 6 months before enrolment.
• Treatment with rituximab in the 12 months before enrolment.
• Abnormal laboratory parameters: creatinine > 1.5 times the upper normal limit (UNL), lactate dehydrogenase (LDH) > 1.5 times the UNL, C-reactive protein (CRP) > 60 mg/dl,
hemoglobin (Hb) < 10 g/dL.
• Ongoing HIV, hepatitis C and hepatitis B infection.
• Participation in another clinical study (or use of another investigational medicinal product [IMP]) within 3 months prior to enrolment.
• Not able to comply with study procedures and treatment regimen.
• Employee at the study site, or spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse).
• Pregnancy or nursing mother.
• Intention to become pregnant during the course of the study.
• Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception (as defined in Section 4.3) for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.0 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Privigen®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Human normal immunoglobulin G (IgG > 98% purity)
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: The objective of the study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
Primary end point(s): The primary efficacy endpoint will be the responder rate (ie, percentage of responders) based on the Inflammatory Neuropathy Cause and Treatment (INCAT) score, using the following definitions:
• Responders are defined as those subjects who demonstrate a “clinically meaningful improvement”1) between baseline and Week 25.
• Non-responders are defined as those subjects who fulfill 1 of the following 2 conditions:
a. Subjects who demonstrate no “clinically meaningful improvement” between
baseline and Week 25, OR
b. Subjects who are withdrawn from the study for any reason after the start of Privigen treatment without “clinically meaningful improvement”1) at the last study visit.
1) “Clinically meaningful improvement” at a subject level is set at a decrease of at least 1 INCAT score point (except for a change of 1 to 0 solely due to upper limb score).
Secondary Objective: Not applicable.
Timepoint(s) of evaluation of this end point: At baseline and every 3 weeks thereafter until Week 25.
Secondary Outcome(s)
Secondary end point(s): The secondary efficacy endpoints of the study are:
• Change in the INCAT score at completion visit compared to baseline and to last measurement
under the previous IVIG treatment.
• Change in maximum grip strength at completion visit compared to baseline and to last
measurement under the previous IVIG treatment.
• Change in MRC sum score determined in 8 muscle groups at completion visit compared to
baseline and to last measurement under the previous IVIG treatment.
Secondary safety endpoints of the study are:
• AE frequency and severity and relatedness per infusion and subject.
• Vital signs during infusion.
• Changes in the laboratory parameters as compared to baseline.
Pharmacokinetic (PK) endpoints of the study are:
• IgG levels at baseline and at Weeks 7, 13 and 19 (levels determined immediately before and
after IVIG infusion), and at completion visit (Week 25).
Timepoint(s) of evaluation of this end point: Neurological scores at screening, baseline and every 3 weeks thereafter until Week 25.
Safety secondary andpoints per infusion and subject at baseline and every 3 weeks thereafter until Week 25.
Pharmacokinetics at Weeks 7, 13, 19 and 25.
Secondary ID(s)
IgPro10_3001
Source(s) of Monetary Support
CSL Behring GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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