Actively Recruiting
Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Led by Octapharma · Updated on 2025-06-06
30
Participants Needed
6
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
CONDITIONS
Official Title
Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 years and 17 years
- Diagnosed with CIDP according to European Academy of Neurology/Peripheral Nerve Society 2021 guidelines
- Functional impairment due to CIDP with a modified Rankin Scale score of 2 to 5
- Provided written informed consent by parent or guardian and assent by the patient if appropriate
You will not qualify if you...
- Previously diagnosed CIDP patients without any CIDP symptoms
- Known or family history of inherited neuropathy
- Previous failure of immunoglobulin therapy for CIDP
- Use of immunoglobulin or plasma exchange within 8 weeks before baseline, except with confirmed CIDP relapse
- History of deep vein thrombosis in the past year or pulmonary embolism ever
- Unstable corticosteroid or rituximab treatment within the last 8 weeks
- Known or suspected severe allergic reaction to immunoglobulins or PANZYGA components
- Female patients who are breastfeeding, pregnant, planning pregnancy, or not using effective birth control
- History or clinical signs of HIV, hepatitis B, or hepatitis C infections
- Severe liver or kidney disease based on specific laboratory values
- History or suspicion of immunoglobulin A deficiency with antibodies
- History of alcohol or drug abuse in the previous year
- Unable or unwilling to follow the study protocol
- Participation in other investigational drug studies within 3 months prior
- Any condition that may interfere with study participation or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Octapharma Research Site
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Octapharma Research Site
Orange, California, United States, 92868
Actively Recruiting
3
Octapharma Research Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
Octapharma Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Octapharma Research Site
Houston, Texas, United States, 77030
Actively Recruiting
6
Octapharma Research Site
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
P
Patrick Murphy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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