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A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care | Clinical Trials | Clareo Health

RECRUITING

A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care

A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to HyQvia

NCT06538064•Takeda

View on ClinicalTrials.gov

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 therapy, how satisfied they are with HyQvia and their previous treatment, how their work productivity and activity is impacted and learn about their CIDP signs and symptoms. Other aims are to collect information on any medical problems or side effects during the treatment with HyQvia, learn how effective treatment of CIDP with HyQvia is and understand details on the use of HyQvia in standard clinical routine as well on the need for healthcare intervention (such as emergency room visits or hospital visits or stays). During the study, data will be collected from medical records already available, interviews with participants at study start and study completion and via questionnaires completed by participants. Participants will be treated as per the doctor's or the clinic's routine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.
+1 more criteria

Locations (15)

Samir Macwan MD Inc

Rancho Mirage, California, United States

Neuro/Psych Sleep Clinic

San Francisco, California, United States

Yale School Of Medicine

New Haven, Connecticut, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

HSHS St. Elizabeths Hospital

O'Fallon, Illinois, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

Wake Forest University - School of Medicine - Central

Winston-Salem, North Carolina, United States

Arhus Universtitetshospital

Aarhus N, Denmark

Key Dates

Start Date

April 29, 2025

Primary Completion Date

August 17, 2027

Completion Date

August 17, 2027

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

No Intervention

OTHER

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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