NCT01581593

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Kedrion S.p.A. · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).

Detailed description

People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs. The standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection. Kedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.

Conditions

• Primary Immunodeficiency
• Agammaglobulinemia
• Hypogammaglobulinemia
• Antibody Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Kedrion IVIG 10%	Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months

Timeline

• Start date: 2012-11-12
• Primary completion: 2014-08-27
• Completion: 2014-08-27
• First posted: 2012-04-20
• Last updated: 2021-02-16
• Results posted: 2021-02-16

Locations

15 sites across 2 countries: United States, Canada