Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
PANZYGA is a human immunoglobin solution with 10% protein content for intravenous (IV) administration.
Octapharma Research Site
Birmingham, Alabama, United States
RECRUITINGOctapharma Research Site
Orange, California, United States
RECRUITINGOctapharma Research Site
Louisville, Kentucky, United States
Change in CIDP Baseline
Evaluate the efficacy of two PANZYGA dose regimens in pediatric CIDP patients based on change in CIDP symptoms, measured by the Modified Rankin Score. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6.
Time frame: Up to 24 weeks
CIDP Relapse
Evaluate percentage of patients with CIDP relapse between 2 doses of Panzyga with relapse defined as increase in Modified Rankin score by ≥1 point from the baseline score related to CIDP. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6.
Time frame: Up to 24 weeks
Time to CIDP Relapse
Time to CIDP relapse or withdrawal for any other reason with with relapse defined as increase in Modified Rankin Score score by ≥1 point from the baseline score. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6.
Time frame: Up to 24 weeks
Percentage of Patients With Good/Excellent Response
The percentage of patients with good/excellent response, defined by a Modified Rankin Score score of 0 or 1 in each arm at Week 24. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6.
Time frame: Up to 24 weeks
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Octapharma Research Site
Philadelphia, Pennsylvania, United States
RECRUITINGOctapharma Research Site
Houston, Texas, United States
RECRUITINGOctapharma Research Site
Charlottesville, Virginia, United States
RECRUITING