A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Kedrion S.p.A.
Summary
The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
Description
This is a Double Blind, Randomized study. All subjects will enter a wash-out phase of up to 12 weeks, or until functional deterioration, defined as an increase of ≥1 point (worsening) in the adjusted INCAT disability score, is demonstrated. Eligible subjects will then be randomized in a 1:2 ratio to receive either 0.5 g/kg or 1.0 g/kg KIg10 at 3-weekly intervals for 21 weeks. Subjects who relapse during randomized treatment due to functional deterioration, based on the INCAT score, will be rescued with 2.0 g/kg KIg10 at 3-weekly intervals for 21 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, aged ≥18 years. 2. Written informed consent and authorization to access personal health information obtained independently from subjects indicating that they understand the purpose of, and procedures required for, the study and are willing to participate. 3. Documented diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) consistent with the 2021 EAN/PNS criteria. 4. Current or documented history of significant disability, as defined by an overall adjusted INCAT disability score between 2 and 9. A score of 2 must be exclusively fr…
Interventions
- BiologicalImmune globulin (human) 10% solution for intravenous administration
Kedrion intravenous immunoglobulin (IVIg) 10%
Locations (2)
- USF Health - Morsani Center for Advanced HealthcareTampa, Florida
- Advanced Neurology Epilepsy and Sleep Center/ANESC ResearchEl Paso, Texas