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
Who is this study for? Patients with pediatric chronic inflammatory demyelinating polyradiculoneuropathy
What treatments are being studied? Panzyga
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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).
Locations
United States
Alabama
Octapharma Research Site
RECRUITING
Birmingham
California
Octapharma Research Site
RECRUITING
Orange
Kentucky
Octapharma Research Site
RECRUITING
Louisville
Pennsylvania
Octapharma Research Site
RECRUITING
Philadelphia
Texas
Octapharma Research Site
RECRUITING
Houston
Virginia
Octapharma Research Site
RECRUITING
Charlottesville
Contact Information
Primary
Patrick Murphy
ctgov@clinicalresearchmgt.com
866-337-1868
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Experimental: Panzyga High Dose
2.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.
Experimental: Panzyga Low Dose
1.0g/kg of PANZYGA administered intravenously every four weeks over a period of sixteen weeks for a total of five treatment dosages.
Related Therapeutic Areas
Sponsors
Leads: Octapharma