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: 17.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-004157-24-FI
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-19
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Subjects unable to directly transition from pivotal study IgPro20_3003, i.e., the subject ins unable to have the baseline visit conducted at the same time as the completion visit for the pivotal study IgPro20_3003
• New medical condition and/or social behavior (i.e. alcohol, drug, or medication abuse) during participation in pivotal 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.
• Pregnant or intention to become pregnant during the course of the study.
• Female subjects of childbearing potential either not using, or not willing to continue to use, a medically reliable method of contraception for the entire duration of the study.

Study & Design

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