Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)

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: EUCTR2013-004157-24-DE

Lead Sponsor: CSL Behring GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).

- 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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Subject is unable to directly transition from study IgPro20_3003.

- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of IMP, and/or conduct of the study.

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 IgPro20. ;Secondary Objective: - To evaluate the long-term safety of IgPro20 by dose. <br><br>- To evaluate the efficacy of IgPro20.<br><br><br><br>;Primary end point(s): Overall Rate rate of adverse events (AEs) per infusion;Timepoint(s) of evaluation of this end point: Up to 49 weeks<br><br>

Secondary Outcome Measures