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We're sorry, but this trial is no longer enrolling volunteers.

Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003

Description

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • 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 Immunoglobulin G (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. Exclusion Criteria:
  • 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)

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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