Could a tailored IVIg dose tame a rare nerve disorder in kids?
NCT ID NCT04929236
First seen Jul 16, 2026 · Last updated Aug 06, 2026 · Updated 3 times
Summary
This phase 3 trial tests two different doses of Panzyga, an intravenous immunoglobulin therapy, in children aged 2 to 17 with CIDP, a rare nerve condition causing weakness and disability. The study aims to see which dose better controls symptoms and prevents relapses, using a disability scale to measure changes. Participants receive Panzyga infusions and are monitored for safety and effectiveness over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Panzyga, a human immunoglobulin solution given intravenously
- What this could lead to
- If successful, this trial could identify the best dose of Panzyga to control CIDP symptoms and prevent relapses in children, offering a safer, more effective treatment option.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to all children. The treatment may cause side effects like allergic reactions or headaches.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥2 years and ≤17 years. 2. Patients with a diagnosis of CIDP based on European Academy of Neurology/Peripheral Nerve Society (EANPNS) 2021 guidelone \[1\] 3. Clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥2, but ≤5. 4. Voluntarily given written informed consent (provided by patient's parent or legal guardian) and assent (provided by the patient, if age appropriate per Independent Ethics Committee \[IEC\]/Institutional Research Board \[IRB\] requirements). Exclusion Criteria: 1. Patients with previously diagnosed CIDP who lack any CIDP symptoms. 2. Patients with a known history of inherited neuropathy or a family history of inherited neuropathy. 3. Patients who have previously failed immunoglobulin therapy for CIDP. 4. Patients who received immunoglobulin or plasma exchange (PEX) within eight weeks prior to the Baseline Visit (washout phase). However, if a patient has clinical evidence of confirmed CIDP relapse during the washout phase (consistent with an increase in mRS of ≥1), they are eligible for trial enrolment. 5. Patients with a history of deep vein thrombosis (DVT) in the past year, or pulmonary embolism ever. 6. Patients on unstable (change in prescribed dose within the last eight weeks) corticosteroids or rituximab use. 7. Patients with known or suspected hypersensitivity, anaphylaxis, or severe systemic response to immune-globulins, blood or plasma derived products, or any component of PANZYGA. 8. Female patients who are breastfeeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on the study (acceptable methods of birth control for this study include: intrauterine device \[IUD\], hormonal contraception, male or female condom, spermicide gel, diaphragm, sponge, or cervical cap). 9. Presence of medical history information or clinical symptoms suggestive of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infections. 10. Severe liver and/or kidney disease (alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\]; aspartate aminotransferase \[AST\] \> 3 × ULN; and/or creatinine levels \>44 µmol/L for children ages 2-3 years, \>62 µmol/L for children ages 4-10 years, and \>89 µmol/L for children ages 11-17 years. 11. Presence of medical history information or clinical symptoms suggestive of immunoglobulin (IgA) deficiency and antibodies against IgA. 12. History of alcohol or drug abuse in the previous year, per Investigator's opinion. 13. Unable or unwilling to comply with the study protocol. 14. Receipt of any other investigational medicinal product (IMP) within three months before study entry or participating in another interventional clinical study. Prior participation in an observational or open-label study involving an approved product may be allowed but require prior consultation with the Medical Monitor to assess eligibilty. 15. Any other condition(s) that, in the Investigator's opinion, makes it undesirable for the patient to participate in the study or may interfere with protocol compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Octapharma Research Site
RECRUITINGBirmingham, Alabama, 35233, United States
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Octapharma Research Site
RECRUITINGOrange, California, 92868, United States
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Octapharma Research Site
RECRUITINGLouisville, Kentucky, 40202, United States
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Octapharma Research Site
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Octapharma Research Site
RECRUITINGHouston, Texas, 77030, United States
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Octapharma Research Site
RECRUITINGCharlottesville, Virginia, 22908, United States