Recruiting

HyQvia

Sponsor:

Takeda

Code:

NCT06538064

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Study ID

NCT06538064

Start date

Apr 29, 2025

Status verified date

Nov, 2025

Completion date

Aug 17, 2027

Anticipated

Primary completion date

Aug 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

No Intervention

This is a non-interventional study.

Primary outcome measure

  • Treatment Preference for CIDP Therapy as Measured by Novel Treatment Preference Questionnaires [ Time Frame: Baseline up to 12 months (HyQvia or study discontinuation) ]
  • Treatment Satisfaction With HyQvia as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Short Form-9 [ Time Frame: Baseline up to 12 months ]
  • Health-Related Quality of Life (HRQoL) as Measured by the Chronic Acquired Polyneuropathy Patient Reported Index (CAP-PRI) [ Time Frame: Baseline up to 12 months ]
  • CIDP Signs, Symptoms, and Impacts, as Measured by the Inflammatory Rasch-built Overall Disability Scale (I-RODS) [ Time Frame: Baseline up to 12 months (HyQvia or study discontinuation) ]
  • Productivity as Measured by the Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline up to 12 months ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327medinfoUS@takeda.com

Locations

Samir Macwan MD Inc

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Site Contact

760-531-4068smacwan@southlandneuromuscular.com

Principal Investigator:

Samir Macwan

Neuro/Psych Sleep Clinic

Recruiting

San Francisco, California, United States, 94143

Contacts

Site Contact

415-353-2273pritikanta.paul@ucsf.edu

Principal Investigator:

Pritikanta Paul

Nova Clinical Research, LLC

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Site Contact

941-792-6564sanjay.yathiraj@novaclinicalresearch.com

Principal Investigator:

Sanjay Yathiraj

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Site Contact

808-564-6141kliow@hawaiineuroscience.com

Principal Investigator:

Kore Liow

HSHS St. Elizabeths Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Contact

618-641-5803raghav.govindarajan@hshs.org

Principal Investigator:

Raghav Govindarajan

University of Kansas Medical Center Research Institute, Inc.

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Contact

913-588-6922mpasnoor@kumc.edu

Principal Investigator:

Mamatha Pasnoor

Wake Forest University - School of Medicine - Central

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Contact

336-716-2357rgandhi@wakehealth.edu

Principal Investigator:

Rachana Gandhi Mehta

More Information

Sponsor

Takeda

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Takeda on 2025-11-21.