NCT00151840

Efficacy and Safety of IVIG-L in ITP Patients

Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Prothya Biosolutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.

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 infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage. In addition to donor selection and screening, several procedures have been included in the production process to improve viral safety. In this clinical trial, the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature. IVIG-L will also be studied in patients with hypogammaglobulinemia.The results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands.

Conditions

• Purpura, Thrombocytopenic, Idiopathic

Interventions

Type	Name	Description
DRUG	IVIG-L

Timeline

• Start date: 2001-10-01
• Completion: 2002-03-01
• First posted: 2005-09-09
• Last updated: 2006-01-31

Locations

6 sites across 1 country: Poland