RecruitingPhase 3NCT06752356

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)


Sponsor

Kedrion S.p.A.

Enrollment

161 participants

Start Date

Oct 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Immune globulin (human) 10% solution for intravenous administration for people with chronic inflammatory demyelinating polyneuropathy. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALImmune globulin (human) 10% solution for intravenous administration

Kedrion intravenous immunoglobulin (IVIg) 10%


Locations(5)

New England Institute for Clinical Research

Stamford, Connecticut, United States

Quantix Research

Miami, Florida, United States

USF Health - Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Advanced Neurology Epilepsy and Sleep Center/ANESC Research

El Paso, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06752356


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