Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 18.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-003448-28-FI
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 276
1. Definite or probable CIDP according to the EFNS/PNS criteria 2010.
2. An IVIG treatment during the last 8 weeks prior to enrollment.
3. Age =18 years.
4. Male or female.
5. Written informed consent for study participation obtained before undergoing any study specific 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
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
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.;Secondary Objective: - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo.<br>- To investigate the safety and tolerability of IgPro20 in comparison to placebo.<br>- To investigate the safety and efficacy of IgPro10 re-stabilization therapy.<br>- To investigate the safety and efficacy of IgPro10 rescue therapy.;Primary end point(s): Efficacy:<br>Percentage (%) of subjects who have a CIDP relapse during SC treatment or are withdrawn from the study during SC treatment for any reason.;Timepoint(s) of evaluation of this end point: During SC treatment period - 24 weeks
- Secondary Outcome Measures
Name Time Method