Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Phase 3

Completed

• Conditions: Primary Immunodeficiency
• Interventions: Drug: Intravenous immunoglobulin infusion

• Registration Number: NCT01985373
• Lead Sponsor: Prothya Biosolutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Study Start: 2013-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
• Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
• A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
• Age >= 18 years
• The patient has signed the consent form

Exclusion Criteria

• Known with allergic reactions against human plasma or plasma products
• Having an ongoing progressive disease, including HIV infection
• Pregnancy or lactation
• Known with insufficiency of coronary or cerebral circulation
• Having renal insufficiency (plasma creatinin > 115µmol/L)
• Having IgA deficiency and anti-IgA antibodies have been detected

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous immunoglobulin infusion	Intravenous immunoglobulin infusion	One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)

Primary Outcome Measures

Name	Time	Method
Cmax	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
elimination rate constant(s)	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
half-life	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
IgG trough levels	before infusion	Comparison IVIG 5% and 10%
plasma concentration-time curve	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
area under the curve	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
volume of distribution	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%
Tmax	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose	Comparison IVIG 5% and 10%

Secondary Outcome Measures

Name	Time	Method
Adverse Events	from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)	number and type

Trial Locations

Locations (4)

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

LUMC; 🇳🇱 Leiden, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands