Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)

Phase 1

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); MedDRA version: 19.0Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-003448-28-DE
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Definite or probable CIDP according to the EFNS/PNS criteria 2010.
2. Repeated treatment with IVIG (= 4 doses) within the last 9 months prior to enrollment.
3. An IVIG treatment during the last 8 weeks prior to enrollment.
4. Age =18 years.
5. Male or female.
6. Written informed consent for study participation obtained before undergoing any studyspecific
procedures.
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Any polyneuropathy of other causes
2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
4. History of thrombotic episodes within the 2 years prior to enrolment
5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG

Study & Design

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