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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jüdisches Krankenhaus Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Not yet recruiting |
| Immanuel Klinik Rüdersdorf Coordinator of this site? Confirm its status | Rüdersdorf | Germany | Recruiting |
| Arhus Universtitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | København Ø | Denmark | Recruiting |
| Nova Clinical Research, LLC Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Hawaii Pacific Neuroscience Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| University of Kansas Medical Center Research Institute, Inc Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Not yet recruiting |
| HSHS St. Elizabeths Hospital Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| Samir Macwan MD Inc Coordinator of this site? Confirm its status | Rancho Mirage | United States | Recruiting |
| Neuro/Psych Sleep Clinic Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Suncoast Neuroscience Associates, Inc. Coordinator of this site? Confirm its status | St. Petersburg | United States | Not yet recruiting |
| Wake Forest University - School of Medicine - Central Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.