Clinical Trial: Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating

  • Number of participants experiencing any treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of participants experiencing causally related serious adverse events (SAEs) and/or adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of participants with serious and/or non-serious adverse reactions (ARs) plus suspected ARs [ Time Frame: Throughout the study period of approximately 5 years ]
  • Rate of adverse events (AEs) that may be a result of immune-mediated responses [ Time Frame: Throughout the study period of approximately 5 years ]
    Expressed as the number of events per infusion and per particpant-year
  • Number of infusions associated with treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs), regardless of causality [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of infusions associated with causally related serious adverse events (SAEs) and/or adverse events (AEs) [ Time Frame: Throughout the study period of approximately 5 years ]
  • Number of infusions temporally associated with adverse events (AEs) [ Time Frame: during or within 72 hours after completion of an infusion ]
    Defined as AEs occurring during or within 72 hours after completion of an infusion
  • Number of infusions associated with serious and/or non-seri

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Baxalta US Inc.

    Dates:
    Date Received: November 2, 2016
    Date Started: November 2016
    Date Completion: December 2021
    Last Updated: November 21, 2016
    Last Verified: November 2016