NCT06538064 A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
| NCT ID | NCT06538064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Takeda |
| Condition | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-08-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-04-29 with a primary completion date of 2027-08-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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. * (Cohort A) only: Participants who do not initiate HyQvia treatment within 6 weeks after enrollment.
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT06538064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06538064 currently recruiting?
Yes, NCT06538064 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT06538064 trial being conducted?
This trial is being conducted at Rancho Mirage, United States, San Francisco, United States, New Haven, United States, Bradenton, United States and 11 additional locations.
Who is sponsoring the NCT06538064 clinical trial?
NCT06538064 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 30 participants.