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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-29

Study Completion Date

2027-08-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

NCT06968975

Polyneuropathy, Inflammatory Demyelinating, Chronic

RECRUITING

A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

NCT07091630

Chronic Inflammatory Demyelinating Polyneuropathy CIDP Chronic Inflammatory Demyelinating Polyradiculoneuropathy

RECRUITING PHASE3

An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT04825626

Chronic Inflammatory Demyelinating Polyneuropathy

NO_LONGER_AVAILABLE

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

NCT05581199

Chronic Inflammatory Demyelinating Polyneuropathy

ACTIVE_NOT_RECRUITING PHASE2

Vitaccess Real CIDP Registry

NCT07006597

Chronic Inflammatory Demyelinating Polyneuropathy CIDP

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A: New Users of HyQvia

Participants with CIDP who intend to switch to HyQvia within 6 weeks after enrollment will be interviewed and data from medical records will be reviewed for 12 months.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Cohort B: Current Users of HyQvia

Participants with CIDP who switched to HyQvia within 6 weeks prior to enrollment will be interviewed and data from medical records will be reviewed for 12 months.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No