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

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Brief Title

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

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 Polyradiculoneuropathy (CIDP)

Brief Summary

      Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have
      completed study 161403 will be able to take part in this study.

      The main aim of the study is to evaluate side effects in the long-term treatment with
      HYQVIA/HyQvia.

      All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study
      161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in
      study 161505 if the study doctor determines that it is safe to do so.

      Participants will visit the clinic within 1 week after the first and second dose of
      HYQVIA/HyQvia and then every 12 weeks for the duration of the study.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality


Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

HYQVIA

Study Arms / Comparison Groups

 HYQVIA
Description:  Subjects will continue to receive HYQVIA/HyQvia infusions every 2, or 3, or 4 weeks (±3 days) following the same dose and dosing regimen of the Phase 3 pivotal study (Study 161403).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

85

Start Date

December 12, 2016

Completion Date

September 30, 2023

Primary Completion Date

September 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Has completed Epoch 1 of Study 161403 without CIDP worsening.

          2. 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:

          1. Participant has a serious medical condition such that the participant's safety or
             medical care would be impacted by participation in this Extension Study.

          2. 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.

          3. Participant is scheduled to participate in another non-Baxalta clinical study
             involving an IP or investigational device during the course of this study.

          4. The participant is nursing or intends to begin nursing during the course of the study

          5. 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
             161403) involving an IP or investigational device during the course of this study.

          6. The participant is a family member or employee of the investigator.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT02955355

Organization ID

161505

Secondary IDs

2016-000374-37

Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Collaborators

 Takeda Development Center Americas, Inc.

Study Sponsor

Study Director, Study Director, Takeda


Verification Date

March 2022