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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: 13 June 2016
Main ID:  EUCTR2013-001428-20-DK
Date of registration: 06/06/2013
Prospective Registration: Yes
Primary sponsor: Aarhus University Hospital
Public title: Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy
Scientific title: Randomized, single-blind crossover study of subcutaneous immunoglobulin in newly diagnosed patients with chronic inflammatory demyelinating polyradiculoneuropathy
Date of first enrolment: 06/06/2013
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001428-20
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Denmark
Contacts
Name: Lars Markvardsen   
Address:  Noerrebrogade 44 8000 Aarhus C Denmark
Telephone: 004578463337
Email: larsmark@rm.dk
Affiliation:  Aarhus University Hospital, Department of Neurology
Name: Lars Markvardsen   
Address:  Noerrebrogade 44 8000 Aarhus C Denmark
Telephone: 004578463337
Email: larsmark@rm.dk
Affiliation:  Aarhus University Hospital, Department of Neurology
Key inclusion & exclusion criteria
Inclusion criteria:
Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and electrophysiological criteria for definite or probable CIDP.
Age > 18 and < 80 years at inclusion
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
Age < 18 and > 80 years at inclusion
Pregnancy
Increased coagulation time (INR > 1.5, thrombocyte count < 100 million/ml)
Malignancies
Other causes of neuropathy (Diabetes mellitus, MGUS)
Severe medical diseases
Other immunomodulating treatment in the last 6 weeks
Hepatitis B and C or HIV
Lactation
Allergy to immunoglobulin
Known Immunoglobulin A deficiency


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
MedDRA version: 16.0 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Trade Name: Privigen
Product Name: Privigen
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Human normal immunoglobulin
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To assess efficacy of immunoglobulin administered subcutaneously compared to intravenous administration in de-novo patients with CIDP
Primary end point(s): Changes in dynamometric muscle strength, measured by Biodex System 3 dynamometer, of four preselected and affected muscle groups from baseline until last evaluation
Secondary Objective: To assess the differencies and changes in muscle strength between subcutanoeus and intravenous administration
Timepoint(s) of evaluation of this end point: All patients are evaluated 7 times during the study period:
0, 2, 5, 10, 12, 15 and 20 weeks after inclusion
Secondary Outcome(s)
Secondary end point(s): Changes in other scores defining muscle strength and disability
- Clinical muscle strength (MRC)
- Grip strength
- 9-hole-peg test
- 40-meter-walking test
- INCAT Overall Disability Sum Score (ODSS)

- Plasma IgG levels
Timepoint(s) of evaluation of this end point: All patients are evaluated 7 times during the study period:
0, 2, 5, 10, 12, 15 and 20 weeks after inclusion
Secondary ID(s)
2012-100
Source(s) of Monetary Support
Aarhus University Hospital, Department of Neurology
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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