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NCT06538064Recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
31 Jul 2024
Start date
29 Apr 2025
Primary completion date
17 Aug 2027
Lead sponsor
Takeda
NCT number
NCT06538064
EU CT number
2024-512690-26-00

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 29 Apr 2025 to the primary completion date, 17 Aug 2027
  • 15 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Participants with known hypersensitivity to any component of HyQvia.

Other

  • Pregnant or breastfeeding.
  • 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.

Who the study is looking for

  • 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 \[sub-study\].

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jüdisches Krankenhaus Berlin
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
Katholisches Klinikum Bochum gGmbH
Coordinator of this site? Confirm its status
BochumGermanyRecruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Coordinator of this site? Confirm its status
MarburgGermanyNot yet recruiting
Immanuel Klinik Rüdersdorf
Coordinator of this site? Confirm its status
RüdersdorfGermanyRecruiting
Arhus Universtitetshospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Rigshospitalet
Coordinator of this site? Confirm its status
København ØDenmarkRecruiting
Nova Clinical Research, LLC
Coordinator of this site? Confirm its status
BradentonUnited StatesRecruiting
Hawaii Pacific Neuroscience
Coordinator of this site? Confirm its status
HonoluluUnited StatesRecruiting
University of Kansas Medical Center Research Institute, Inc
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Yale School of Medicine
Coordinator of this site? Confirm its status
New HavenUnited StatesNot yet recruiting
HSHS St. Elizabeths Hospital
Coordinator of this site? Confirm its status
O'FallonUnited StatesRecruiting
Samir Macwan MD Inc
Coordinator of this site? Confirm its status
Rancho MirageUnited StatesRecruiting
Neuro/Psych Sleep Clinic
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Suncoast Neuroscience Associates, Inc.
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesNot yet recruiting
Wake Forest University - School of Medicine - Central
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.