Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 16.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-004157-24-IT
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
- Subjects having participated in the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
- If treatment for CIDP is required, it has to include IgGs.
- Subjects who completed study IgPro20_3003 before study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after study IgPro20_3004 is open for enrollment at the site.
- Subjects who completed study IgPro20_3003 after study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after the completion visit of study IgPro20_3003
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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- Any polyneuropathy of other causes
- Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
- Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
- History of thrombotic episodes within the 2 years prior to enrolment
- Known allergic or other severe reactions to blood products including intolerability to previous IVIG (normal human immunoglobulin for intravenous administration) and/or SCIG (subcutaneous immunoglobulin)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate long-term safety of high-dose IgPro20 in subjects who have participated in the SC Treatment Period of pivotal study IgPro20_3003;Secondary Objective: Secondary objectives: <br>• To evaluate the long-term safety of low-dose IgPro20. <br>• To evaluate the long-term efficacy of high-dose and low-dose IgPro20.<br><br>;Primary end point(s): Overall rate of adverse events (AEs) per infusion - high-dose IgPro20<br>;Timepoint(s) of evaluation of this end point: Up to 48 weeks<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety:<br>1. Rate of adverse events (AEs) per infusion by severity, causality, and seriousness - high-dose IgPro20<br>2. Percentage of subjects with adverse events (AEs) - high-dose IgPro20<br>3. Rate of adverse events (AEs) per infusion - low-dose IgPro20<br>4. Percentage of subjects with adverse events (AEs) - low-dose IgPro20<br>Efficacy:<br>1. Total INCAT score at all study visits<br>2. Time to first CIDP relapse<br>;Timepoint(s) of evaluation of this end point: Safety 1. and 2.= Up to 48 weeks<br>Safety 3. and 4.= Up to 28 weeks<br><br>Efficacy 1.= Up to 49 weeks (baseline [Week 1], Weeks 2, 9, 17, 25, 33, 41, and at completion visit)<br>Efficacy 2.= Up to 49 weeks<br>