World Health Organization site
Skip Navigation Links

Main
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 September 2020
Main ID:  EUCTR2017-002024-24-DK
Date of registration: 19/06/2017
Prospective Registration: Yes
Primary sponsor: Aarhus Unversity Hospital
Public title: Systematic reduction in dosage of subcutanoeus immunoglobulin in patients with chronic inflammatory neuropathy
Scientific title: Randomized, cohort study of standardized reduction of subcutaneous immunoglobulin treatment in patients with chronic inflammatory demyelinating polyneuropathy
Date of first enrolment: 08/09/2017
Target sample size: 60
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002024-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
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
Name: Lars Markvardsen   
Address:  Noerrebrogade 44 8000 Aarhus C Denmark
Telephone: 004578463337
Email: larsmark@rm.dk
Affiliation:  Aarhus University Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
Diagnosed with CIDP
Treated with subcutaneous immunoglobulin in unaltered dosage for at least 3 months
Age > 18 years
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
Other forms of neuropathy or myopathy treated with SCIG
Age < 18 years
Pregnancy or breast feeding


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyneuroapthy
MedDRA version: 20.0 Level: LLT Classification code 10077384 Term: Chronic inflammatory demyelinating polyneuropathy System Organ Class: 100000014567
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Gammanorm
Product Name: Gammanorm
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 165-

Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Trade Name: Subcuvia
Product Name: Subcuvia
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Immunoglobulin
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

Primary Outcome(s)
Main Objective: To identify the lowest effective dosage of subcutaneous immunoglobulin in maintenance treatment of CIDP
Primary end point(s): Change in overall disability sum score (ODSS)
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: Evaluation every 3rd month, where dose of SCIG is reduced further if no deterioration occur
Secondary Outcome(s)
Secondary end point(s): Changes in muscle strength (MRC, isokinetic muscle strength, grip strength)
Changes in sensory modality (INCAT SSS)
Changes in disability (9-hole-peg-test, six-spot-step-test, 10-meter-walk-test)
Changes in quality of life, fatigue and pain (RODS, EQ-5D-5L, FSS, NPSI)
Timepoint(s) of evaluation of this end point: Same as for primary endpoint
Secondary ID(s)
AUH-2016-100
Source(s) of Monetary Support
Danish Regions
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 06/09/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history