Study of the effect of subcutaneous administration of immunoglobulin in patients with newly diagnosed chronic inflammatory demyelinating polyradiculoneuropathy

Phase 1

• Conditions: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP); MedDRA version: 16.0Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001428-20-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified