NCT03166527

Panzyga in CIDP Administered at Different Infusion Rates

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vera Bril · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Interventions

Type	Name	Description
DRUG	Immune Globulin 10% Intravenous Solution	standard Immune lobulin 10% intravenous solution infusion at standard and high infusion rates.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-12-15
• Completion: 2018-12-15
• First posted: 2017-05-25
• Last updated: 2017-05-25

Locations

1 site across 1 country: Canada