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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01184846
Date of registration: 18/08/2010
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
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: November 2010
Target sample size: 31
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01184846
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Belgium Finland France Germany Poland
Contacts
Name:     Program Director Clinical R&D
Address: 
Telephone:
Email:
Affiliation:  CSL Behring
Key inclusion & exclusion criteria

Inclusion Criteria:

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.

- Actual diagnosis (including electrophysiology) 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.

- Age =18 years.

- Male or female.

- Written informed consent for study participation obtained before undergoing any study
specific procedures.

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 and 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).

- Historic 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.

- Age =18 years.

- Male or female.

- Written informed consent for study participation obtained before undergoing any study
specific procedures.

Exclusion Criteria:

- A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with
conduction block (i.e., 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).

- CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS
antibodies and patients 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 radiculopathy,
post-polio-syndrome,M. Parkinson, stroke).

- Current malignancy.

- History of 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) > 1.5 times
the UNL, 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 for the entire duration of the study, or
not sexually abstinent for the entire duration of the study, or not surgically
sterile.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Biological: 10% liquid formulation of human immunoglobulin
Primary Outcome(s)
Responder Rate [Time Frame: 25 weeks]
Secondary Outcome(s)
Change in Adjusted INCAT Score [Time Frame: Up to 34 weeks]
Change in Maximum Grip Strength [Time Frame: Up to 34 weeks]
Change in Medical Research Council Sum Scale (MRC) [Time Frame: Up to 34 weeks]
Frequency of Adverse Events (AEs) [Time Frame: For the duration of the study, up to 34 weeks]
Immunoglobulin G (IgG) Level [Time Frame: At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)]
Mean Change in Body Temperature During Infusion [Time Frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.]
Mean Change in Pulse Rate During Infusion [Time Frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.]
Mean Change in Systolic and Diastolic Blood Pressure During Infusion [Time Frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.]
Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters. [Time Frame: At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)]
Relatedness of AEs Per Infusion [Time Frame: For the duration of the study, up to 34 weeks]
Relatedness of AEs Per Subject [Time Frame: For the duration of the study, up to 34 weeks]
Severity of AEs Per Infusion [Time Frame: For the duration of the study, up to 34 weeks]
Severity of AEs Per Subject [Time Frame: 34 weeks]
Secondary ID(s)
1504
2009-017672-24
IgPro10_3001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 04/04/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01184846
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