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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    148
  • sponsor
    Baxalta now part of Shire
Updated on 27 January 2022
immunoglobulins
igiv
immune globulin
polyradiculoneuropathy
recombinant human hyaluronidase
hyqvia

Summary

The purpose of this phase IIIb 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 without CIDP worsening.

Details
Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Treatment HYQVIA
Clinical Study IdentifierNCT02955355
SponsorBaxalta now part of Shire
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Has completed Epoch 1 of Study 161403 without CIDP worsening
If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study

Exclusion Criteria

Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study
New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study
Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study
The participant is nursing or intends to begin nursing during the course of the study
Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study
involving an IP or investigational device during the course of this study
The participant is a family member or employee of the investigator
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