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Immunoglobulin
Open Label study for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (Panzyga-CIDP Trial)
Phase 3
Waitlist Available
Research Sponsored by Vera Bril
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a treatable form of peripheral neuropathy with suspected autoimmune cause. The current first-line treatment is IVIG (immune globulin), which is infused in a set regimen that requires 4-5 hours in a hospital day unit, taking up resources such as nursing time and hospital space. Chronic treatment is required in most cases.
Eligible Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of all adverse events with focus on adverse drug reactions (ADRs)
Secondary study objectives
grip strength
health utilities
proportion of patients successfully achieving higher infusion rates
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Open Label studyExperimental Treatment1 Intervention
open label study using Panzyga immune globulin 10% intravenous solution with no placebo.
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Who is running the clinical trial?
Vera BrilLead Sponsor
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