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: ClinicalTrials.gov
Last refreshed on: 28 September 2015
Main ID:  NCT02111590
Date of registration: 09/04/2014
Prospective Registration: Yes
Primary sponsor: Rigshospitalet, Denmark
Public title: Immunoglobulin Dosage and Administration Form in CIDP and MMN
Scientific title: The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN
Date of first enrolment: January 2014
Target sample size: 36
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02111590
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Johannes Jakobsen, DMSc
Address: 
Telephone:
Email:
Affiliation:  Neuroscience Center, Rigshospitalet
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed with CIDP or MMN fulfilling the EFNS/PNS criteria

- Maintenance treatment with IVIG or SCIG for at least 3 months

- Negative result on a pregnancy test (HCG-based assay in urine) for women of
childbearing potential and use of a reliable method of contraception for the duration
of the study

Exclusion Criteria:

- Pure sensory or severe ataxic CIDP

- Other cause of neuropathy (incl. pressure neuropathy)

- Known history of adverse reactions to IgA in other products

- Exposure to blood or any blood product or plasma derivatives, other than Privigen,
within the past 3 months prior to first infusion of Gammanorm

- Ongoing history of hypersensitivity or persistent reactions to blood or plasma
derived products.

- Requirement of any routine premedication for IgG administration

- History of malignancies of lymphoid cells and immunodeficiency with lymphoma

- Severe liver function impairment (ALAT 3 times above upper limit of normal)

- Known protein-losing enteropathies or proteinuria.

- Live viral vaccination (such as measles, rubella, mumps and varicella) within the
last 2 months prior to first infusion of Gammanorm

- Treatment with any investigational medicinal product within 3 months prior to first
infusion of Gammanorm

- Medication interfering with hematopoiesis

- Other immunomodulation therapy than low dose steroid (Prednisolone < 25 mg daily)

- Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals
within the past 12 months prior to first infusion of Gammanorm

- Known or suspected HIV, HCV, or HBV infection

- Pregnant or nursing women

- Planned pregnancy during course of the study



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Hemolytic Anemia
Multifocal Motor Neuropathy
Intervention(s)
Drug: Immunoglobulins
Primary Outcome(s)
Variation in blood hemoglobin during treatment with IVIG and SCIG [Time Frame: Twenty weeks]
Secondary Outcome(s)
Variation in blood hemoglobin during treatment with two preparations of SCIG [Time Frame: Twenty weeks]
Variation in muscle strength during treatment with IVIG and SCIG [Time Frame: Twenty weeks]
Variation in muscle strength during treatment with two preparations of SCIG [Time Frame: Twenty weeks]
Secondary ID(s)
2013-400-RH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aarhus University Hospital
Octapharma Pharmazeutika Produktionsges.m.b.H.
Ethics review
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