NCT00138697

Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients

Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: Prothya Biosolutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.

Detailed description

Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage. In addition to the donor selection and donor screening, several viral safety steps have been included into the production process. In this clinical trial, the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic ITP (KB98001). Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands.

Conditions

• Hypogammaglobulinemia

Interventions

Type	Name	Description
DRUG	IVIG-L

Timeline

• Start date: 2001-05-01
• Completion: 2004-12-01
• First posted: 2005-08-30
• Last updated: 2007-04-19

Locations

6 sites across 1 country: Netherlands