Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxalta now part of Shire
With
Takeda Development Center Americas, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
