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

Recruiting now

Conditions studied: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

In brief

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.

Key facts

Study ID

NCT06538064

Run by

Takeda

People needed

30

Starts

2025-04-29

Expected to finish

2027-08-17

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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].

You may not qualify if…

• 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.

Where it is running

• Samir Macwan MD Inc — Rancho Mirage, California, United States (enrolling)
• Neuro/Psych Sleep Clinic — San Francisco, California, United States (enrolling)
• Arhus Universtitetshospital — Aarhus N, Denmark (enrolling)
• Rigshospitalet — København Ø, Denmark (enrolling)
• Immanuel Klinik Rudersdorf — Rüdersdorf, Brandenburg, Germany (enrolling)
• Katholisches Klinikum Bochum gGmbH — Bochum, North Rhine-Westphalia, Germany (enrolling)
• Nova Clinical Research, LLC — Bradenton, Florida, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• HSHS St. Elizabeths Hospital — O'Fallon, Illinois, United States (enrolling)
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States (enrolling)
• Wake Forest University - School of Medicine - Central — Winston-Salem, North Carolina, United States (enrolling)
• Yale School Of Medicine — New Haven, Connecticut, United States
• Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg — Marburg, Hesse, Germany
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Judisches Krankenhaus Berlin — Berlin, Germany

Full record on ClinicalTrials.gov

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