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Tests treatment safety and results for Pediatric Chronic Inflammatory Demyelinating...
Official title Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
ClinicalTrials.gov ID: NCT04929236
What this study is testing
What is Panzyga?
Panzyga is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric chronic inflammatory demyelinating polyneuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Age ≥2 years and ≤17 years.
- Patients with a diagnosis of CIDP based on European Academy of Neurology/Peripheral Nerve Society (EANPNS) 2021 guidelone [1]
- Clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥2, but ≤5.
- Voluntarily given written informed consent (provided by patient's parent or legal guardian) and assent (provided by the patient, if age appropriate...
You likely can't join if
- Patients with previously diagnosed CIDP who lack any CIDP symptoms.
- Patients with a known history of inherited neuropathy or a family history of inherited neuropathy.
- Patients who have previously failed immunoglobulin therapy for CIDP.
- Patients who received immunoglobulin or plasma exchange (PEX) within eight weeks prior to the Baseline Visit (washout phase). However, if a patient...
- Patients with a history of deep vein thrombosis (DVT) in the past year, or pulmonary embolism ever.
- Patients on unstable (change in prescribed dose within the last eight weeks) corticosteroids or rituximab use.
See the full eligibility criteria
- Age ≥2 years and ≤17 years.
- Patients with a diagnosis of CIDP based on European Academy of Neurology/Peripheral Nerve Society (EANPNS) 2021 guidelone [1]
- Clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥2, but ≤5.
- 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...
- Patients with previously diagnosed CIDP who lack any CIDP symptoms.
- Patients with a known history of inherited neuropathy or a family history of inherited neuropathy.
- Patients who have previously failed immunoglobulin therapy for CIDP.
- 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...
- Patients with a history of deep vein thrombosis (DVT) in the past year, or pulmonary embolism ever.
- Patients on unstable (change in prescribed dose within the last eight weeks) corticosteroids or rituximab use.
- Patients with known or suspected hypersensitivity, anaphylaxis, or severe systemic response to immune-globulins, blood or plasma derived products, or any component of PANZYGA.
- 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...
- 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.
- 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...
- Presence of medical history information or clinical symptoms suggestive of immunoglobulin (IgA) deficiency and antibodies against IgA.
- History of alcohol or drug abuse in the previous year, per Investigator's opinion.
- Unable or unwilling to comply with the study protocol.
- Receipt of any other investigational medicinal product (IMP) within three months before study entry or participating in another treatment clinical study. Prior participation in an observational or open-label study...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Orange, California, United States
- Louisville, Kentucky, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Orange, California, United States; Louisville, Kentucky, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.