Status:
RECRUITING
A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
Lead Sponsor:
Takeda
Conditions:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Eligibility:
All Genders
18+ years
Brief Summary
The main aims of this study are to understand why adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) chose a certain treatment, why they changed to HyQvia from another therap...
Eligibility Criteria
Inclusion
- Participants aged 18 years or older.
- Investigator-confirmed documented diagnosis of CIDP of any type (e.g., typical, multifocal, focal, motor, sensory, or distal) according to the revised European Academy of Neurology and Peripheral Nerve Society (EAN/PNS) 2021 guidelines on the diagnosis and treatment of CIDP.
- Participants must currently have a stable disease course (as per physician judgment) for at least 12 weeks.
- Is considered a new user or current user of HyQvia-
- New users (Cohort A) are participants on a CIDP treatment as of the date of enrollment, who intend to switch to HyQvia within 6 weeks after enrollment.
- Current users (Cohort B) are participants on HyQvia as of the date of enrollment, who switched to HyQvia within the 6 weeks preceding the date of enrollment (the 6-week window may be extended depending on the recruitment progress).
- Has provided written informed consent (for the main study).
- Participant is willing to comply with the protocol requirement of non-standard of care (non-SOC) assessments (e.g., adjusted inflammatory neuropathy cause and treatment (INCAT) assessment).
- Participants must be able to communicate fluently in their local language (if they participate in the optional qualitative participant interview \[sub-study\].
Exclusion
- Had any HyQvia use, defined as
- any record of HyQvia use prior to enrollment for new users of HyQvia (Cohort A), and
- any record of HyQvia use more than 6 weeks preceding the enrollment date (the 6-week window may be extended depending on the recruitment progress) for current users of HyQvia (Cohort B).
- Without any prior treatment for CIDP.
- Pregnant or breastfeeding.
- Participants with known hypersensitivity to any component of HyQvia.
- Has participated in an interventional clinical study within 30 days prior to enrollment or was scheduled to participate in an interventional clinical study during this study.
- Has had major surgery within 12 weeks prior to enrollment, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgeries.
- Received induction treatment for CIDP during the past 12 weeks.
- Participant is identified by the investigator as being unable or unwilling to cooperate with the study procedures.
- (Cohort A) only: Participants who do not initiate HyQvia treatment within 6 weeks after enrollment.
Key Trial Info
Start Date :
April 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 17 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06538064
Start Date
April 29 2025
End Date
August 17 2027
Last Update
November 21 2025
Active Locations (15)
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1
Samir Macwan MD Inc
Rancho Mirage, California, United States, 92270
2
Neuro/Psych Sleep Clinic
San Francisco, California, United States, 94143
3
Yale School Of Medicine
New Haven, Connecticut, United States, 06510
4
Nova Clinical Research, LLC
Bradenton, Florida, United States, 34209