NCT01985373

Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Prothya Biosolutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.

Conditions

• Primary Immunodeficiency

Interventions

Type	Name	Description
DRUG	Intravenous immunoglobulin infusion	Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-11-15
• Last updated: 2015-04-06

Locations

4 sites across 1 country: Netherlands