Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
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 [IRB] requirements).
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 phase (consistent with an increase in mRS of ≥1), they are eligible for trial enrolment.