Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Clinical Trial
Official title:
Prospective, Open-Label, Phase IIIb Study Evaluating the Safety, Tolerability and Efficacy of Panzyga® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Administered at Standard and High Infusion Rates
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.
The proposed trial will be an exploratory, open-label, single-centre, phase IIIb safety,
tolerability and efficacy study, wherein each patient acts as their own control. The primary
outcome measure is safety and tolerability of panzyga in patients with active CIDP at
standard and high infusion rates as measured by:
- Occurrence of all adverse events with focus on adverse drug reactions (ADRs)
- The secondary outcomes include: Patients' treatment satisfaction, proportion of
patients successfully achieving higher infusion rates, health utilities associated with
treatment, proportion of responders to treatment based on change in clinical scores,
grip strength, and quality of life measures. The total sample size is 25-30 patients,
based on a difference of 30% in adverse events rates between the standard infusion rate
and the maximum rate tolerated by each patient.
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