Understanding the use of HyQvia in adults with CIDP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather insights on why adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) choose HyQvia as a treatment, including their satisfaction levels and the impact on their daily activities and work productivity. Data will be collected through medical records, participant interviews at the start and completion of the study, and questionnaires. The study will also assess the effectiveness of HyQvia and any side effects experienced during treatment, as well as the need for healthcare interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Samir Macwan MD Inc
  Rancho Mirage, California, United States Recruiting
• Neuro/Psych Sleep Clinic
  San Francisco, California, United States Recruiting
• Nova Clinical Research, LLC
  Bradenton, Florida, United States Recruiting
• Hawaii Pacific Neuroscience
  Honolulu, Hawaii, United States Recruiting
• HSHS St. Elizabeths Hospital
  O'Fallon, Illinois, United States Recruiting
• University of Kansas Medical Center Research Institute, Inc.
  Kansas City, Kansas, United States Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing TAK-411 for treating CIDP in adults

  This study is testing a new treatment called TAK-411 to see if it can help adults with CIDP feel better and improve their physical abilities.

  Recruiting at 22 sites Phase 2 Takeda · La Jolla, California and 21 other locations · NCT06798012

• Comparing TAK-881 and HYQVIA as maintenance treatment for adults with CIDP

  This test will see if TAK-881 given under the skin works like HYQVIA for adults with CIDP who are already on IgG therapy.

  Recruiting at 16 sites Phase 3 Takeda · Scottsdale, Arizona and 51 other locations · NCT06747351

• Weekly subcutaneous XEMBIFY versus every-3-week intravenous Gamunex-C for CIDP

  This will test whether weekly under-the-skin XEMBIFY gives similar blood IgG levels as Gamunex-C given into a vein every three weeks in people with CIDP.

  Recruiting at 15 sites Phase 3 Grifols Therapeutics LLC · Rancho Mirage, California and 15 other locations · NCT07540221

• Real-world efgartigimod use in adults with CIDP

  This study will see if efgartigimod helps adults with CIDP when given as part of routine clinical care.

  Recruiting at 22 sites argenx · Wilmington, North Carolina and 22 other locations · NCT07264426

• Empasiprubart for adults with CIDP

  This study will test whether IV empasiprubart helps improve symptoms and is safe for adults with CIDP, with an initial 24-week randomized comparison to placebo followed by two years of empasiprubart for all participants.

  Recruiting at 94 sites Phase 3 argenx · Birmingham, Alabama and 93 other locations · NCT07091630

• BAFF‑R CAR T‑cell treatment for refractory neuroimmune diseases

  This trial will try personalized BAFF‑R CAR T cells to reduce disease activity in people with hard‑to‑treat conditions such as CIDP, NMOSD, myasthenia gravis, and inflammatory myopathies.

  Recruiting Phase 1/2 Tianjin Medical University General Hospital · Tianjin, Tianjin Municipality · NCT07022197

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.