Multicenter, Prospective, Double-Blinded, Parallel Group, Randomized Phase III Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Octapharma
Summary
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPanzyga
PANZYGA is a human immunoglobin solution with 10% protein content for intravenous (IV) administration.
Locations (6)
- Octapharma Research SiteBirmingham, Alabama
- Octapharma Research SiteOrange, California
- Octapharma Research SiteLouisville, Kentucky
- Octapharma Research SitePhiladelphia, Pennsylvania
- Octapharma Research SiteHouston, Texas
- Octapharma Research SiteCharlottesville, Virginia