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 Demyelina

Brief Summary: The purpose of this study is to assess the long-term safety, tolerability, and immunogenicity of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous (IGSC) facilitated with recombinant human hyaluronidase (rHuPH20) (HYQVIA/HyQvia) in participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) who have completed Baxalta Clinical Study Protocol 161403 Epoch 1 or Clinical Study Protocol 161601 without CIDP worsening.

Detailed Summary:
Sponsor: Baxalta US Inc.

Current Primary Outcome:

• 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