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